Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

De Jonge (2016)

SR and meta-analysis of  RCTs

Literature search up to November 2015.

A: Arslan (2014)

B: Baracs (2011)

C: Chen (2011)

D: Defazio (2005)

E: Diener (2014)

F: Ford (2005)

G: Galal (2011)

H: Isik (2012)

I: Justinger (2013)

J: Khachatryan (2011)

K: Mattavelli (2015)

L: Mingmalairak (2009)

M: Nakamura (2013)

N: Rasic (2011)

O: Rozelle (2008)

P: Seim (2012)

Q: Singh (2010)

R: Thimour Bergstrom (2013)

S: Turtianen (2012)

T: Williams (2011)

U: Yam (2013)

Study design: RCT [parallel / cross-over], cohort [prospective / retrospective], case-control

Setting and Country:

Source of funding

Conflicts of interest:

[commercial / non-commercial / industrial co-authorship]

Inclusion criteria SR:

• All RCTs comparing the effect of TCS on the incidence of SSI with that of exactly the same, but uncoated, sutures.

Exclusion criteria SR:

• In vitro studies;
• Animal studies;
• Non-randomized studies;
• Studies with incomparable suture types in the control group.

20 studies included

Important patient characteristics at baseline:

N total (analyzed)

A: N = 177 (N = 177)

B: N = 485 (N = 385)

C: N = 241 (N = 241)

D: N = 93 (N = 93)

E: N = 1224 (N = 1185)

F: N = 151 (N = 147)

G: N = 450 (N = 450)

H: N = 510 (N = 510)

I: N = 967 (N = 856)

J: N = 133 (N = 133)

K: N = 300 (N = 281)

L: N = 100 (N = 100)

M: N = 410 (N = 410)

N: N = 184 (N = 184)

O: N = 84 (N = 84)

P: N = 328 (N = 323)

Q: N = 100 (N = 100)

R: N = 392 (N = 374)

S: N = 276 (N = 276)

T: N = 150 (N = 127)

U: N = 26 (N = 26)

mean age

Not reported.

Sex:

Not reported.

Groups comparable at baseline?

Yes.

Describe intervention:

A: TCS

B: TCS

C: TCS

D: TCS

E: TCS

F: TCS

G: TCS

H: TCS

I: TCS

J: TCS

K: TCS

L: TCS

M: TCS

N: TCS

O: TCS

P: TCS

Q: TCS

R: TCS

S: TCS

T: TCS

U: TCS

Describe control:

A: NCS

B: NCS

C: NCS

D: NCS

E: NCS

F: NCS

G: NCS

H: NCS

I: NCS

J: NCS

K: NCS

L: NCS

M: NCS

N: NCS

O: NCS

P: NCS

Q: NCS

R: NCS

S: NCS

T: NCS

U: NCS

End-point of follow-up:

A: 30 days.

B: 30 days after discharge, by telephone.

C: not reported.

D: 6 weeks.

E: 30 days.

F: 80 days.

G: 30 days or 1 year.

H: 30 days

I: 2 weeks after discharge.

J: not reported.

K: 30 days

L: 30 days, 6 months, 1 year.

M: 30 days.

N: to discharge.

O: 6 months.

P: 4 weeks.

Q: 30 days.

R: 60 days.

S: 30 days.

T: 6 weeks.

U: not reported.

Outcome measure: SSI

High-quality peer-reviewed full-text publications

E (Diener, 2014)

I: 87/587 (

C: 96/598

R (Thimour Bergstrom, 2013)

I: 23/184

C: 38/190

S (Turtianen, 2012)

I: 31/139

C: 164/925

Other peer-reviewed full-text publications

B (Baracs, 2011)

I: 23/188

C: 24/197

C (Chen, 2011)

I: 17/112

C: 19/129

F (Ford, 2005)

I: 3/98

C: 0/49

G (Galal, 2011)

I: 17/230

C: 33/220

H (Isik, 2012)

I: 9/170

C: 22/340

I: Justinger, 2013)

I: 31/485

C: 42/371

K (Mattavelli, 2015)

I: 18/140

C: 15/141

L (mingmalairak, 2009)

I: 5/50

C: 4/50

M (Nakamura, 2013)

I: 9/206

C: 19/204

N (Rasic, 2011)

I: 4/91

C: 12/93

O (Rozzelle, 2008)

I: 2/46

C: 8/38

P (Seim, 2012)

I: 16/160

C: 17/183

T (Williams, 2011)

I: 10/66

C: 14/61

Congress abstracts

A (Arslan, 2014)

I: 8/86

C: 18/91

D (Defazio, 2005)

I: 4/43

C: 4/50

J (Khachatryan, 2011)

I: 6/65

C: 14/68

Q (Singh, 2010)

I: 6/50

C: 16/50

U (Yam, 2013)

I: 1/12

C: 5/14

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Ruiz-Tovar (2015)

Type of study:

Multi-center RCT

Setting and country:

Spain.

Funding and conflicts of interest:

No competing financial interests exist.

Inclusion criteria:

• Intra-operative diagnosis of fecal peritonitis secondary to acute diverticulitis perforation, Neoplastic tumor perforation, or colorectal anastomotic leak of previous elective colorectal resection.

Exclusion criteria:

• Post-operative mortality.

N total at baseline:

Intervention: N = 55

Control: N = 55

Important prognostic factors²:

age ± SD:

I: 65.6 (14.9)

C: 63.8 (15.5)

Sex:

I: 31/51 M

C: 31/50 M

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Sutures coated with triclosan

Describe control (treatment/procedure/test):

No triclosan-coated sutures.

Length of follow-up:

5, 30, and 60 days after surgery.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 5/55

C: 18/55

Author’s conclusion:

The use of triclosan-coated sutures in fecal peritonitis surgery reduces the incidence of incisional SSI.

Steingrimsson (2015)

Type of study:

Randomized controlled trial, single-center.

Setting and country:

Sweden.

Funding and conflicts of interest:

A.J. has received speaker’s honorarium from Ethicon, Inc. The authors declare that there are no other conflicts of interest.

Inclusion criteria:

• Patients that underwent elective CABG, either alone or in combination with aortic valve replacement or mitral valve repair/replacement.

Exclusion criteria:

• Preoperative infections such as sepsis, septicemia, other bacterial infections or any antibiotic treatment;
• Previous cardiac surgery;
• Participation in other clinical studies;
• Severe disease that might influence wound healing;
• Emergent surgery;
• Known allergy to triclosan.

N total at baseline:

Intervention: N = 193

Control: N = 200

Important prognostic factors²:

age ± SD:

I: 67.6 (8.1)

C: 66.7 (8.2)

Sex:

I: 22.9% F

C: 15.7% F

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Closure of wounds with triclosan-coated sutures.

Describe control (treatment/procedure/test):

Closure of wounds without triclosan-coated sutures.

Length of follow-up:

4, 30, and 60 days postoperative.

Loss-to-follow-up:

Intervention:

N = 17

Control:

N = 12

Outcome measure: SSI

I: 23/193

C: 20/200

Author’s conclusion:

Renko (2017)

Type of study:

Randomised controlled trial, single center.

Setting and country:

Finland.

Funding and conflicts of interest:

MR received grants from The Alma and K A Snellman Foundation (Oulu, Finland) during the conduct of the study, and grants from The Finnish Medical Foundation and the Foundation for Pediatric Research, outside the submitted work. J-JS received grants from Emil Aaltonen Foundation, Finska Läkaresällskapet Foundation, The Alma and K A Snellman Foundation, Vaasa Foundation of Physicians and personal fees from Bioretec Ltd and MSD Finland Ltd, outside the submitted work.

WS received grants from Foundation for Pediatric Research, outside the submitted work. None of the other authors declare any competing interests.

Inclusion criteria:

• Children younger than 18 years staying in the paediatric surgery and orthopaedics ward for any elective or emergency surgery scheduled for the paediatric operative room during the daytime and with anticipated use of absorbing sutures.

Exclusion criteria:

• Emergency surgeries outside of office hours;
• Children having corrections of the foreskin because of the use of different criteria to monitor the healing of these procedures;
• Patients undergoing procedures because of cleft lip or palate for the same reasons.

N total at baseline:

Intervention: N = 814

Control: N = 819

Important prognostic factors²:

age ± SD:

I: 7.2 (5.4) years

C: 7.1 (5.5) years

Sex:

I: 483 M

C: 502 M

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Sutures with triclosan during surgery.

Describe control (treatment/procedure/test):

Ordinary absorbable sutures during surgery.

Length of follow-up:

30 days after the surgical procedure.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 20/814

C: 42/819

Author’s conclusion:

SSIs cause much morbidity and mortality after surgical procedures, and economic evaluations recommend the use of triclosan-containing material.41,42 This randomised, controlled study shows that even in low-risk settings, where other prophylactic measures are available to use, triclosan-containing sutures effectively prevented the occurrence of SSIs in children.

Soomro (2017)

Type of study:

Randomized controlled trial, single center.

Setting and country:

Pakistan.

Funding and conflicts of interest:

The study has no conflict of interest to declare by any author.

Inclusion criteria:

• Age between 20 to 35 years;
• Benign breast diseases e.gfibroadenoma.

Exclusion criteria:

• Patients with inflammatory and malignant breast diseases;
• Patients with known allergy or intolerance to triclosan;
• Patients with known chronic immune deficiency;
• Patients with previous scare at operative site.

N total at baseline:

Intervention: N = 189

Control: N = 189

Important prognostic factors²:

age ± SD:

I: 25.86 (3.51) years

C: 25.70 (3.10) years

Sex:

No information.

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Triclosan coated-sutures.

Describe control (treatment/procedure/test):

Sutures without triclosan.

Length of follow-up:

3, 7, and 30 days postoperative.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 7/189

C: 11/189

Author’s conclusion:

The study did not demonstrate a statistically significant reduction of superficial surgical site infection when triclosan coated polyglactin suture was used in clean wounds. More studies need to be conducted with larger sample size to look at its effects on other wound categories.

Arslan (2018)

Type of study:

Randomized controlled trial.

Setting and country:

Turkey.

Funding and conflicts of interest:

No information.

Inclusion criteria:

• Patients older than 18 years old who underwent wide excision and primary closure for PD.

Exclusion criteria:

• Immunosuppression;
• Antibiotherapy and/or infection history within 1 week before surgery;
• Acute abscess;
• Recurrent PD;
• Different procedures other than wide excision and primary closure;
• Use of drain;
• Postoperative administration of antibiotics.

N total at baseline:

Intervention: N = 92

Control: N = 95

Important prognostic factors²:

age ± SD:

I: 25.8 (6.5) years

C: 25.5 (5.5) years

Sex:

I: 79 M

C: 76 M

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Triclosan-coated sutures.

Describe control (treatment/procedure/test):

No triclosan-coated sutures.

Length of follow-up:

30 days postoperative.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 9/92

C: 19/95

Author’s conclusion:

Triclosan-coated sutures decreased surgical site infection rate but had no effect on time to healing in pilonidal disease. Seroma and wound dehiscence were more common in triclosan groups. Randomized trials are needed to clear the effect of triclosan-coated sutures on postoperative wound complications.

Ichida (2018)

Type of study:

Randomized controlled trial.

Setting and country:

Japan.

Funding and conflicts of interest:

No information reported.

Inclusion criteria:

• Patients undergoing gastroenterologic surgery.

Exclusion criteria:

• Identification of bacterial infection;
• Use of antibiotic therapy prior to operation;
• Presence of a contaminated abdominal cavity due to intestinal fistula or drainage tube;
• Known allergy to triclosan;
• Pregnancy.

N total at baseline:

Intervention: N = 512

Control: N = 511

Important prognostic factors²:

age ± SD:

I: 67.0 (11.5) years

C: 67.5 (11.6) years

Sex:

I: 304 M

C: 322 M

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Abdominal wound closure with triclosan-coated sutures.

Describe control (treatment/procedure/test):

Abdominal wound closure without triclosan-coated sutures.

Length of follow-up:

30 days.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 35/512

C: 30/511

Author’s conclusion:

Lin (2018)

Type of study:

Randomized controlled trial.

Setting and country:

No information.

Funding and conflicts of interest:

All authors state that they have no conflicts of interest.

Inclusion criteria:

• Men and woman aged 55-85;
• Diagnosis of degenerative osteoarthritis of the knee;
• Not having previously undergone surgery to the index knee.

Exclusion criteria:

• Inflammatory arthritis-rheumatoid arthritis;
• Ankylosing spondylitis;
• Infectious arthritis;
• Systemic lupus erythematosus;
• Psoriatic arthritis.

N total at baseline:

Intervention: N = 51

Control: N = 51

Important prognostic factors²:

age ± SD:

I: 71.3 (7.7)

C: 70.0 (7.1)

Sex:

I: 36 F

C: 40 F

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Triclosan-coated polyglactin sutures.

Describe control (treatment/procedure/test):

Plain polyglactin sutures.

Length of follow-up:

2, weeks, 4 weeks, and 3 months after surgery.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 0/51

C: 2/51

Author’s conclusion:

Triclosan-coated sutures did not cause adverse local or systemic reactions: similar changes in serial inflammatory response occurred in both groups. Furthermore, falling levels of IL-6 imply that triclosan-coated sutures had a positive effect on postoperative knee inflammation. A more sensitive analytical measurement tool is needed to investigate local and systemic complications, especially in the early subclinical stage.

Karde (2019)

Type of study:

Randomized controlled trial.

Setting and country:

Department of periodontology.

Funding and conflicts of interest:

There are no conflicts of interest or external funding.

Inclusion criteria:

• Age of 25-60 years;
• Free of any systemic diseases such as diabetes and hypertension.

Exclusion criteria:

• Patients taking any medication known to affect the outcomes of periodontal therapy;
• Smokers;
• Immunocompromised patients;
• Pregnant and/or lactating woman;
• Patients with any known allergies to chlorhexidine or triclosan;
• Patients who have taken antibiotics in any form in the past 3 months.

N total at baseline:

Intervention: N = 10

Control: N = 10

Important prognostic factors²:

age ± SD:

39.2 (10.76) years

Sex:

13 males and 17 females.

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

TCS

Describe control (treatment/procedure/test):

NCS

Length of follow-up:

30 days.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 0/10

C: 0/10

Author’s conclusion:

TCS or CCS sutures can be used in periodontal surgeries to reduce the bacterial load at the surgical sites.

Olmez (2019)

Type of study:

Randomized controlled trial.

Setting and country:

No information.

Funding and conflicts of interest:

The authors have no financial conflicts of interest related to this manuscript.

Inclusion criteria:

• Patients who were 18 years or older and underwent elective or urgent surgery for any reason.

Exclusion criteria:

• Patients who had triclosan allergy;
• Patients who needed re-laparotomy in the first week after the initial operation;
• Patients who were left with an open abdomen;
• Patients with ASA-score IV;
• Patients who refused randomization.

N total at baseline:

Intervention: N = 450

Control: N = 450

Important prognostic factors²:

age ± SD:

I: 55.1 (16.3) years

C: 54.6 (16.9) years

Sex:

I: 192 M

C: 223 M

Groups comparable at baseline?

Not  for BMI, smoking, previous abdominal midline incision, co-morbidities, ASA class, and target organ for operation.

Describe intervention (treatment/procedure/test):

Triclosan-coated sutures.

Describe control (treatment/procedure/test):

Standard sutures without triclosan-coating.

Length of follow-up:

14 days after surgery.

Loss-to-follow-up:

Intervention: N = 2

Control: N = 4

Outcome measure: SSI

I: 85/450

C: 115/450

Author’s conclusion:

Surgical site infections are an important and expensive healthcare problem around the world. This study found that using triclosan-coated sutures to close the fascia after lap- arotomy reduced the SSI rate by as much as 24%. Although the SSIs had multiple causes, and some of them might have been preventable. In this situation, surgical innovations and clinical research should be prioritized. The use of triclosan- coated suture for closing laparotomy incisions may reduce the rate of SSIs in all subgroups of incision classifications in a single-center experience. We demonstrated that using triclosan-coated suture reduced SSIs in patients with clean, clean-contaminated, and contaminated wounds, especially in colorectal operations, which have a high infection rate.

Santos (2019)

Type of study:

Randomized controlled trial.

Setting and country:

Brazil.

Funding and conflicts of interest:

This study was funded by Ethicon Inc., represented in Brazil by Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda. Grant # 10-107.

This study was funded by Ethicon Inc., represented in Brazil by Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda. Grant # 10-107.

Inclusion criteria:

• Patients who underwent consecutively, prospectively, and exclusively on-pump and off-pump CABG, of both genders, and aged >30 years.

Exclusion criteria:

• Patients undergoing CABG associated with other cardiac surgeries or undergoing vascular surgeries other than CABG;
• Bilateral saphenectomized patients;
• Pregnant women;
• Patients under antibiotic therapy for previous infectious disease up to a month before;
• Immunosuppressed patients;
• Patients with severe peripheral vascular disease;
• History of venous disease of the deep system and superficial thrombophlebitis of the great saphenous vein;
• Patients with psychiatric disorder.

N total at baseline:

Intervention: N = 251

Control: N = 257

Important prognostic factors²:

age ± SD:

I: 62.01 (8.62)

C: 60.39 (9.03)

Sex:

I: 175 (69.7%) M

C: 180 (70%) M

Groups comparable at baseline?

Yes, except for wound pain and wound hyperthermia.

Describe intervention (treatment/procedure/test):

Triclosan-coated 910 sutures.

Describe control (treatment/procedure/test):

Conventional 910 polyglactin suture.

Length of follow-up:

30 days.

Loss-to-follow-up:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measure: SSI

I: 13/251

C: 20/257

Author’s conclusion:

In patients undergoing saphenectomy during CABG, the most frequent variables, such as demographic, clinical, and those related to saphenectomy wounds, were male gender, diabetes, erythema, and necrosis. Pain and hyperthermia in the wound were less frequent in patients sutured with triclosan. The patients with triclosan-coated sutures presented smaller infection rate in saphenectomy than those with non-coated sutures undergoing CABG, although the differences were not statistically significant.

Sukeik (2019)

Type of study:

Randomized controlled trial.

Setting and country:

UK

Funding and conflicts of interest:

No potential conflicts of interest to declare. No external financial support.

Inclusion criteria:

• Adult patients (18 years and older) undergoing primary total hip or knee arthroplasty under the care of one surgical team at our institute.

Exclusion criteria:

• Unilateral primary total hip or knee arthroplasty performed for trauma;
• Revision procedure or a previous incision in the operative field;
• History of tendency for keloid formation;
• Allergy to triclosan/vicryl;
• Bleeding tendency;
• Being on regular anticoagulation treatment;
• Underlying malignancy and immunocompromised status;
• Dementia and mental illnesses preventing informed consent;
• Children (age <18 years).

N total at baseline:

Intervention: N = 81

Control: N = 61

Important prognostic factors²:

age ± SD:

I: 68.85 (10.90) years

C: 67.85 (9.85) years

Sex:

I: 24 M

C: 25 M

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Coated polyglactin 910 sutures with triclosan

Describe control (treatment/procedure/test):

Coated polyglactin 910 sutures.

Length of follow-up:

6 weeks postoperative.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 4/81

C: 1/69

Author’s conclusion:

The current literature supports the use of triclosan-coated sutures in some disciplines of general surgery but the evidence in orthopaedic surgery especially in arthroplasty procedures remains inconclusive. This trial supports the findings from other studies that triclosan-coated sutures do not provide any benefits over non-coated sutures in protecting against wound complications and infections after hip and knee arthroplasty surgery. Therefore, we recommend against the routine use of those sutures and advise that efforts should continue to emphasise the benefits of preventative measures against infections and explore new modalities of reducing surgical site infections. The utilisation of a well-designed randomised controlled trial will help in answering whether any of those new modalities will stand the challenge of time and optimal outcomes.

Tabrizi (2019)

Type of study:

Randomized controlled trial.

Setting and country:

Iran.

Funding and conflicts of interest:

The authors declare no conflict of interest. The manuscript did not meet any conflict of interest.

Shahid Beheshti University of Medical Sciences funded the research.

Inclusion criteria:

• Patients scheduled to undergo dental implant surgery and receive three dental implants in the posterior mandible.

Exclusion criteria:

• Diabetics or smokers;
• Poor oral hygiene;
• Patients who needed hard and soft tissue augmentation.
• Patients who required bone augmentation due to exposed threads during insertion.

N total at baseline:

Intervention: M = 160

Control: N = 160

Important prognostic factors²:

age ± SD:

I: 44.73 (12.82) years

C: 44.64 (12.24) years

Sex:

I: 83 M

C: 77 M

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Triclosan-coated sutures

Describe control (treatment/procedure/test):

Conventional sutures.

Length of follow-up:

28 days postoperative.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 12/160

C: 11/160

Author’s conclusion:

In conclusion, triclosan-coated Vicryl sutures did not decrease the incidence of surgical site infection following dental implant surgery. The incidence of dehis- cence was slightly higher in the Vicryl Plus group, which calls for further caution when using Vicryl Plus sutures.

Ruiz-Tovar (2019)

Type of study:

Randomized controlled trial.

Setting and country:

Not reported.

Funding and conflicts of interest:

No information reported.

Inclusion criteria:

• Patients undergoing emergent surgery by laparotomy and midline approach, for community-acquired infection, peritoneal contamination secondary to perforation of the digestive tract, and ischemia of a segment of digestive tract requiring resection.

Exclusion criteria:

• Patients with immune deficiencies or intake of immunodepressive drugs and nosocomial infection.
• Patients with post-enrollment events or lost to follow-up during the first 30 days postoperatively;
• Patients planned for a second-look surgery.

N total at baseline:

Intervention: N = 50

Control: N = 50

Important prognostic factors²:

age ± SD:

I:

C:

Sex:

I: % M

C: % M

Groups comparable at baseline?

Describe intervention (treatment/procedure/test):

Polydioxanone plus loop

Describe control (treatment/procedure/test):

Standard polydioxanone loop suture.

Length of follow-up:

30 days postoperatively.

Loss-to-follow-up:

None.

Outcome measure: SSI

I: 5/50

C: 13/50

Author’s conclusion:

The use of triclosan-coated sutures in emergent surgery reduced the incidence of incisional SSI, postoperative pain, and analytical acute phase reactants. The use of barbed sutures reduced the incidence of evisceration. Triclosan-coated barbed sutures can be considered as rec- ommended sutures for aponeurotic closure in emergent mid-line approaches.

NIHR Global Research Health Unit on Global Surgery (FALCON) 2021

Type of study:

Randomized controlled trial.

Setting and country:

Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa.

Funding and conflicts of interest:

National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

We declare no competing interests.

Inclusion criteria:

• Adult and paediatric patients undergoing abdominal surgery;
• Operation was predicted to be clean-contaminated, or contaminated or dirty, with a planned skin incision of 5 cm or greater.

Exclusion criteria:

• Allergy to iodine, shellfish, or chlorhexidine skin preparation solution;
•  Patients anticipated to be unable to complete either in-person or telephone follow-up;
• Patients with an abdominal incision planned for healing by secondary intention.

N total at baseline:

Intervention: N = 2895

Control: N = 2893

Important prognostic factors²:

age >18 years

I: N = 2895

C: N = 2893

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

Triclosan coated sutures

Describe control (treatment/procedure/test):

Non-coated sutures.

Length of follow-up:

30 days after surgery.

Loss-to-follow-up:

Intervention: N = 18

Control: N = 12

Outcome measure: SSI

I: 562/2895

C: 601/2893

Author’s conclusion:

Both overall and per stratum reported SSI rates were high, confirming that specific assessment of patients for SSIs will lead to their highest detection.26 This finding highlights the quality of the FALCON trial processes, including proactive training of masked outcome assessors and high completion of follow-up. These very high SSI rates represent a preventable complication that is causing unnecessary suffering and burden to patients and systems. Small randomised trials should now be avoided and should be replaced with larger trials that can more robustly identify or refute pragmatic solutions.

de Jonge 2017

Cruz 2013

Different PICO (pomade: iodoform plus calendula coating)

Delieart 2009

Different PICO (SSI not assessed)

Fleck 2007

No RCT (retrospective study)

Fujita 2014

No RCT (commentary)

Heger 2011

No RCT (study protocol)

Hoshino 2013

No RCT (retrospective study)

Huszár 2012

Duplicate data of Baracs 2011

Jeppsson 2012

Duplicate data of Thimour-Bergrström 2013

Justinger 2011

No RCT (non-randomized study)

Mattavelli 2011

Duplicate data of Mattavelli 2015

Mattavelli 2013

Duplicate data of Mattavelli 2015

Okada 2014

No RCT (non-randomized trial)

Picó 2008

Different PICO (triclosan versus gentamicin coating)

Rogers 2012

No RCT (commentary)

Sakaguchi 2009

Duplicate data of Singh 2010

Sprowson 2014

No RCT (study protocol)

Stone 2010

No RCT (follow-up of Rozzelle 2008)

Zhang 2011

Control group not comparable

Zhuang 2009

Control group not comparable

Update

Carella 2019

Different PICO (triclosan versus chlorhexidine coating)

ChiCTR2000031795

No RCT (study protocol)

Diener 2014

Already included

Dixit 2018

Different PICO (triclosan versus triclosan coating)

DRKS00010047

No RCT (study protocol of Matz 2019)

Karde 2019

Different PICO (SSI not assessed)

Lozano 2020

No RCT (non-randomized study)

Mattavelli 2015

Already included

Matz 2019

No RCT (study protocol)

McCallum 2016

No RCT (study protocol, withdrawn)

Miyoshi 2022

No RCT (non-randomized study)

NCT02533492

No RCT (study protocol of Lin 2018)

NCT02847936

No RCT (study protocol of Mbarki 2022)

NCT02863874

No RCT (study protocol)

NCT03386240

No RCT (study protocol)

NCT03659344

No RCT (study protocol of Tabrizi 2019)

NCT03763279

No RCT (study protocol of Ruiz-Tovar 2020)

NCT04255927

No RCT (study protocol)

NCT04256824

No RCT (study protocol)

NCT04622267

No RCT (study protocol)

Roy 2019

Different PICO (chlorhexidine versus chlorhexidine coating)

Serlo 2016

Duplicate data of Renko 2017

Sprowson 2018

Quasi-randomisation (per month)

Tae 2018

Different PICO (chlorhexidine versus chlorhexidine coating)

UMIN000021892

No RCT (study protocol)

Carella S, Fioramonti P, Onesti MG, Scuderi N. Comparison between antimicrobial-coated sutures and uncoated sutures for the prevention of surgical site infections in plastic surgery: a double blind control trial. Eur Rev Med Pharmacol Sci. 2019;23(3):958-964.

ChiCTR2000031795. http://www.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000031795

Cruz F, Leite F, Cruz G, Cruz S, Reis J, Pierce M et al. Sutures coated with antiseptic pomade to prevent bacterial colonization: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol 2013; 116: e103–e109.

Deliaert AE, Van den Kerckhove E, Tuinder S, Fieuws S, Sawor JH, Meesters-Caberg MA et al. The effect of triclosan-coated sutures in wound healing. A double blind randomised prospective pilot study. J Plast Reconstr Aesthet Surg 2009; 62: 771–773.

Dixit A, Nadkarni P, Thakkar A. Safety and efficacy of triclosan-coated polyglactin 910 suture in prevention of surgical site infection in postpartum women : A randomized controlled trial. J Ind Med Ass 2018; 116.

DRKS00010047, https://www.cochranelibrary.com/central/doi/10.1002/central/CN-01852897/full

Fleck T, Moidl R, Blacky A, Fleck M, Wolner E, Grabenwoger M et al. Triclosan-coated sutures for the reduction of sternal wound infections: economic considerations. Ann Thorac Surg 2007; 84: 232–236.

Fujita T. Antibiotic sutures against surgical site infections. Lancet 2014; 384:1424–1425.

Heger U, Voss S, Knebel P, Doerr-Harim C, Neudecker J, Schuhmacher C et al. Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial. Trials 2011; 12: 245.

Hoshino S, Yoshida Y, Tanimura S, Yamauchi Y, Noritomi T, Yamashita Y. A study of the efficacy of antibacterial sutures for surgical site infection: a retrospective controlled trial. Int Surg 2013; 98: 129–132.

Huszár O, Baracs J, Tóth M, Damjanovich L, Kotán R, Lázár G et al. [Comparison of wound infection rates after colon and rectal surgeries using triclosan-coated or bare sutures – a multi-center, randomized clinical study.]. Magy Seb 2012; 65: 83–91.

Jeppsson A, Thimour-Bergström L, Gudbjartsson T, Aneman C, Friberg O. Triclosan-coated sutures reduce surgical site infections after open vein harvesting in coronary artery bypass graft patients: a prospective randomized controlled trial. Interactive Cardiovascular and Thoracic Surgery Conference: 26th Annual Meeting of the European Association for Cardio-Thoracic Surgery, EACTS 2012, Barcelona, 27–31 October 2012; 15: S134.

Justinger C, Schuld J, Sperling J, Kollmar O, Richter S, Schilling MK. Triclosan-coated sutures reduce wound infections after hepatobiliary surgery-a prospective non-randomized clinical pathway driven study. Langenbecks Arch Surg 2011; 396: 845–850.

Karde PA, Sethi KS, Mahale SA, Mamajiwala AS, Kale AM, Joshi CP. Comparative evaluation of two antibacterial-coated resorbable sutures versus noncoated resorbable sutures in periodontal flap surgery: A clinico-microbiological study. J Indian Soc Periodontol. 2019;23(3):220-225.

Lozano CC, Garcia-Botello S, Martí-Arévalo, Bauzá Collado J, Pla Martí V et al. P1668 Use of triclosan-coated barbed monifilmaent suture (TCBMS) to reduce surgical site infection in elective colorectal surgery. American Society of Colon and Rectal Surgeons 2020 Anuual Scientifici Meeting abstracts. 2020: 60:3 e441.

Mattavelli I, Nespoli L, Alfieri S, Cantore F, Sebastian-Douglas S, Cobianchi L et al. Triclosan-coated suture to reduce surgical site infection after colorectal surgery. Surg Infect (Larchmnt) 2011; 12: A14–A15.

Mattavelli I, Nespoli L, Alfieri S, Cantore F, Cobianchi L, Luperto M et al. Effect of triclosan-coated suture on surgical site infection after colorectal surgery: final results of a multicenter, prospective, randomized trial. Surg Infect (Larchmnt) 2013; 14: A9.

Matz D, Teuteberg S, Wiencierz A, Soysal SD, Heizmann O. Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial. Trials. 2019;20(1):390.

NCT02533492, https://clinicaltrials.gov/ct2/show/NCT02533492 

NCT02847936, https://clinicaltrials.gov/ct2/show/NCT02847936

NCT02863874, https://clinicaltrials.gov/ct2/show/NCT02863874

NCT03386240, https://clinicaltrials.gov/ct2/show/NCT03386240 

NCT03659344, https://clinicaltrials.gov/ct2/show/NCT03659344

NCT03763279, https://clinicaltrials.gov/ct2/show/NCT03659344

NCT04255927, https://clinicaltrials.gov/ct2/show/NCT04255927 

NCT04256824, https://clinicaltrials.gov/ct2/show/NCT04256824

NCT04622267, https://clinicaltrials.gov/ct2/show/NCT04622267

Okada N, Nakamura T, Ambo Y, Takada M, Nakamura F, Kishida A et al. Triclosan-coated abdominal closure sutures reduce the incidence of surgical site infections after pancreaticoduodenectomy. Surg Infect (Larchmnt) 2014; 15: 305–309.

Picó RB, Jiménez LA, Sánchez MC, Castelló CH, Bilbao AM, Arias MP et al. [Prospective study comparing the incidence of wound infection following appendectomy for acute appendicitis in children: conventional treatment versus using reabsorbable antibacterial suture or gentamicin-impregnated collagen fleeces.] Cir Pediatr 2008; 21:199–202.

Rogers P. Effect of triclosan-coated sutures on incidence of surgical wound infection after lower limb revascularization surgery: a randomized controlled trial. By Turtiainen et al. DOI:10.1007/s00268-012-1655-4. World J Surg 2012; 36: 2535–2536.

Roy PK, Kalita P, Lalhlenmawia H, Dutta RS, Thanzami K, Zothanmawia C. Comparison of surgical site infection rate between antibacterial coated surgical suture and conventional suture: a randomized controlled single centre study for preventive measure of postoperative infection. 2019 International Journal of Pharmaceutical Sciences and Research, 10, 2385-91.

Sakaguchi H, Singh H, Klima U, Lee C, Kofidis T. Antibacterial suture reduces surgical site infections in coronary artery bypass grafting. 17th Annual Meeting of the Asian Society For Cardiovascular and Thoracic Surgery (ASCVTS), Taipei, Taiwan, 5–8 March 2009; 111–114.

Serlo W, Renko M, Paalanne N, Tapaiainen T, Hinkanen M et al. 44th Annual Meeting of International Society for Pediatric Neurosurgery, Kobe, Japan, Oct 23–27, 2016. Child’s Nerv Syst, 32, 1957-2040.

Sprowson AP, Jensen CD, Parsons N, Partington P, Emmerson K, Carluke I et al. The effect of triclosan coated sutures on rate of surgical site infection after hip and knee replacement: a protocol for a double-blind randomised controlled trial. BMC Musculoskelet Disord 2014; 15: 237.

Stone J, Gruber TJ, Rozzelle CJ. Healthcare savings associated with reduced infection rates using antimicrobial suture wound closure for cerebrospinal fluid shunt procedures. Pediatr Neurosurg 2010; 46: 19–24.

Tae BS, Park JH, Kim JK, et al. Comparison of intraoperative handling and wound healing between (NEOSORB® plus) and coated polyglactin 910 suture (NEOSORB®): a prospective, single-blind, randomized controlled trial. BMC Surg. 2018;18(1):45.

UMIN000021892, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025218

Zhang ZT, Zhang HW, Fang XD, Wang LM, Li XX, Li YF et al. Cosmetic outcome and surgical site infection rates of antibacterial absorbable (polyglactin 910) suture compared to Chinese silk suture in breast cancer surgery: a randomized pilot research. Chin Med J (Engl) 2011; 124: 719–724.

Zhuang C, Cai G, Wang Y. Comparison of two absorbable sutures in abdominal wall incision. Journal of Clinical Rehabilitative Tissue Engineering Research 2009; 13: 4045–4048.

Publication

Participants/analyzed

Surgery type

Suture types

CDC wound class

Definition for SSI

Duration of follow up

Perioperative IV antibiotics

Risk of bias

Arslan 2018

Turkey

177 / 177

Pilonidal cyst surgery

Retention:

Polypropylene vs. Polydiaxanone +

Subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Polypropylene vs. Polydiaxanone +

II – III

CDC

30 days

Yes

Some concerns

Baracs 2011

Hungary

485 / 385

Colorectal surgery

- open (100%)

Abdominal fascia:

Polydiaxanone vs. Polydiaxanone +

Skin:

Poliglecaprone 25+

II

CDC

30 days after discharge, by telephone

Yes

High

Chen 2011

Taiwan

241 / 241

Head and neck surgery

Intra-oral flaps:

Silk sutures

Subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Nylon sutures

II

No §

Not described

n.r.

High

Diener 2014

Germany

1224 / 1185

Laparotomy

Abdominal fascia:

Polydiaxanone vs. Polydiaxanone +

Skin:

Staples

I (282)
II (880)
III (20)
IV (3)

CDC

30 days

Yes

Low

Ford 2005

USA

151 / 147

Pediatric general surgery

Polyglactin 910 vs. Polyglactin 910+

I-II

No ¶

80 days

n.r.

Some concerns

Galal 2011

Egypt

450 / 450

Various

Surgical steps:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Poliglecaprone 25 OR Polypropylene

I (236)
II (143)
III (71)

CDC

30 day, 1 year

n.r.

Some concerns

Ichida 2018

Japan

1023 / 1013

Gastroenterologic surgery - open (42%)

- laparoscopy (58%)

Abdominal fascia and peritoneum:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Polydiaxanone vs. Polydiaxanone +

I (9)

II (990)

III (14)

CDC

30d

Yes

Some concerns

Isik 2012

Turkey

510 / 510

Cardiac surgery

Polyglactin 910 vs. Polyglactin 910+

I

CDC

30 days

n.r.

High

Justinger 2013

Germany

967 / 856

Laparotomy

Abdominal fascia:

Polydiaxanone vs. Polydiaxanone +

Subcutis:

No sutures

Skin:

Staples

I (531)
II (259)
III (62)

CDC

2 weeks after discharge

Yes

Some concerns

Karip 2016

Turkey

142 / 106

Pilonidal  cyst surgery with flap reconstruction

Poliglecaprone 25 vs. Poliglecaprone 25+

II – III

No ¶

1, 2 weeks, 1,3, and 6 months

Yes

Some concerns

Lin 2018

Taiwan

102 / 102

Total knee arthroplasty

Arthrotomy, fascial layer, and subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Staples

I

n.r.

3 months

Yes

High

Mattavelli 2015

Italy

300 / 281

Colorectal surgery

- open (19%)

- laparoscopy (81%)

Peritoneum:

Polyglactin 910 vs. Polyglactin 910+

Abdominal fascia:

Polydiaxanone vs. Polydiaxanone+

Subcutis and skin:

Polyglactin 910 vs. Polyglactin 910+

II

CDC

30 days

Yes

Low

Mbarki 2022

Tunisia

340 / 318

Obstetric surgery

Uterus, aponeurosis, subcutis and skin:

Polyglactin 910 vs. Polyglactin 910+

II

CDC

30 days

Yes

Low

Mingmalairak 2009

Thailand

100 / 100

Appendectomy

- open (100%)

Abdominal fascia:

Polyglactin 910 vs. Polyglactin 910+

III (24)
IV (76)

CDC

30 days, 6 months, 1 year

Yes

Some concerns

Nakamura 2013

Japan

410 / 410

Colorectal surgery

- open (45%)

- laparoscopy (55%)

Polyglactin 910 vs. Polyglactin 910+

Skin:

Staples OR interrupted sutures

II (408)
III (2)

CDC

30 days

Yes

Some concerns

NIHR 2021

UK

5788  / 5713

Abdominal surgery

- open (>99%)

- laparoscopy (<1%)

Abdominal fascia:

Unknown vs. Polydiaxanone + (OR  Polyglactin 910+ for children)

II (3091)

III – IV (2697)

CDC

30 days

Yes

Low

Olmez 2019

Turkey

900 / 890

Laparotomy

Abdominal fascia:

Polydiaxanone vs. Polydiaxanone +

Subcutis:

No suture

Skin:

Polypropylene

I (84)

II (651)
III (152)

IV (3)

No ¶

7, 14 and 30 days

Yes

High

Rasic 2011

Croatia

184 / 184

Colorectal surgery

- open (100%)

Single mass layer (peritoneum, muscle, fascia):

Polyglactin 910 vs. Polyglactin 910+

II

n.r.

To discharge

Yes

Some concerns

Renko 2017

Finland

1633 / 1557

Peadiatric surgery

Polyglactin 910 OR  Polydiaxanone OR Poliglecaprone 25

vs.

Polyglactin 910+ OR Polydiaxanone +

OR Poliglecaprone25+

I (1394)

II (53)

III (1)

M (109)

CDC

30 days

Yes (in 31%)

Low

Rozelle 2008

USA

84 / 84

CSF shunt implantation

Galea and fascia:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Poliglecaprone 25

I

No ‡

6 months

Yes

Some concerns

Ruiz-Tovar 2015

Spain

110 / 101

Laparotomy with abdominal wall

closure and fecal peritonitis

Abdominal fascia:

Polyglactin 910 vs. Polyglactin 910+

Subcutis:

No suture

Skin:

Staples

IV

CDC

5, 30 and 60 days

Yes

Some concerns

Ruiz-Tovar 2020

Spain

100 / 92 

Laparotomy with abdominal wall closure

Abdominal fascia:

Polydiaxanone vs. Polydiaxanone +

Subcutis:

No suture

Skin:

Staples

IV

CDC

30 days

Yes

High

Santos 2020

Brazil

583 / 508

Saphenectomy for coronary bypass graft

Skin:

Polyglactin 910 vs. Polyglactin 910+

I

No §

30 days

Yes

Some concerns

Seim 2012

Norway

328/323

Saphenectomy for coronary bypass graft

Skin:

Polyglactin 910 vs. Polyglactin 910+

I

No ‡

4wk

Yes

Some concerns

Soomro 2017

Pakistan

378 / 378

Benign breast surgery

Subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Polyglactin 910 vs. Polyglactin 910+

I

n.r.

3, 7 and 30 days

Yes

High

Steingrimsson 2015

Sweden

392 / 357

Coronary bypass graft

Sternum:

Steel wires

Fascia and subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Poliglecaprone 25 vs. Poliglecaprone 25+

I

CDC, ASEPSIS score

3 and 30 days

Yes

Some concerns

Sukeik 2019

UK

150 / 150

Hip and knee arthroplasty

Surgical steps:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Staples

I

ASEPSIS score

2 and 6 weeks

Yes

Low

Tabrizi 2019

Iran

320 / 320

Dental implant surgery

Polyglactin 910 vs. Polyglactin 910+

II

No §

7, 14, 21 and 28 days

Yes

Some concerns

Thimour-Bergrström 2013

Sweden

392 / 374

Coronary bypass graft

Subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Poliglecaprone 25 vs. Poliglecaprone 25+

I

CDC

60 days

Yes

Low

Turtianen 2012

Finland

276 / 276

Lower limb arterial

reconstruction

Subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Poliglecaprone 25 vs. Poliglecaprone 25+

I

CDC

30 days

Yes

Low

Williams 2011

UK

150 / 127

Mastectomy

Subcutis:

Polyglactin 910 vs. Polyglactin 910+

Skin:

Poliglecaprone 25 vs. Poliglecaprone 25+

I

CDC

6 weeks

Yes

Some concerns

§ Local erythematous change in sutured wound with purulent discharge, cervical wound dehiscence, or neck skin necrosis; ¶ clinical signs of infection; ‡ positive culture

CDC, Centers for Disease Control and Prevention; ROB, risk of bias; SSI, surgical-site infection; SC, single-centre; n.r., not reported; MC, multicentre; M, missing; COI, conflicts of interest; CSF, cerebrospinal fluid.