Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Zehtabchi, 2007

SR and meta-analysis of  RCTs

Literature search up to December 2005.

A: Grossman (1981)

B: Haughey (1981)

C: Roberts and Teddy (1977)

D: Beesley (1975)

Study design: Randomized controlled trials

Setting and Country:

A: USA

B: USA

C: England

D: England

Source of funding and conflicts of interest:

The author reports this study received

no outside funding or support.

Inclusion criteria SR:

• Studies that compared the effectiveness of a systematic antibiotic regimen to placebo for patients with wounds meeting these descriptions;

Exclusion criteria SR:

• Studies that included patients with bite and burn wounds or wounds involving special structures (i.e., tendons, bones, large vessels, and nerves).
• Studies in which subjects were largely treated by surgical specialties or subspecialties.

4 studies included

Important patient characteristics at baseline:

N patients

A: N=265

B: N=394

C: N=368

D: N=145

Mean age:

A: Not reported

B: Not reported

C: Not reported

D: Not reported

Sex:

A: Not reported

B: Not reported

C: Not reported

D: Not reported

Groups comparable at baseline?

Describe intervention

A:

I: Single dose of IM cefazolin (1 g);

II: oral cephalexin 250 mg every 6h for 6 days

B:

Oral cephalexin for 5 days (250 mg every 6h for adults and 6.25 mg/kg/d for children

C:

I: 7 day course or oral flucloxacillin (1 g/d for adults and 0.5 g/d for children <5y, divided in 4 doses/day);

II: single IM dose (1 vial for adults, ½ vial for children 2-10y, and ¼ vial for children <2y) of a combination of procaine, benethamine, and benzyl penicillin patients;

D: 5 day course of oral magnapen (flucloxacillin and ampicillin), 500 mg 4 times a day for 5 days.

Describe control  

A: Single IM dose of placebo

B: No treatment

C: No treatment

D: Placebo capsules 4 times a day for 5 days

End-point of follow-up

 A: not reported

B: 7-10 days

C: 7 days postinjury

D: 5 days postinjury

Wound infection, rate of infection; n/N

A:

Rate of infection intervention: 1.15%; 2/174

Rate of infection control: 1.10%; 1/91

RR= 1.05 (95% CI= 0.09 to 11.38)

C:

Rate of infection intervention: 8.80%; 18/205

Rate of infection control: 12.0%; 12/100

RR= 0.73 (95% CI= 0.37 to 1.46)

D:

Rate of infection intervention: 1.40%; 1/70

Rate of infection control: 1.30%; 1/75

RR= 1.07 (95% CI= 0.07 to 16.80)

*The study of Haughey was excluded from the analysis. This trial was highly susceptible to bias because of use of pseudorandomization according to medical record number. There was also a complete absence of concealment of randomization and of blinding, the lack of the use of a placebo, and a clear violation of intention-to-treat phenomenon involving 20% of the patients initially assigned to active therapy. Furthermore, patients who were lost to follow-up were simply excluded from the study and their numbers were not reported, rendering it impossible to assess the impact of this potential source of bias. These factors make the validity of this trial highly questionable.

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison/ control (C) ³

Follow-up

Outcome measures and effect size ⁴

Halhalli, 2018

Type of study:

A prospective, single-center, randomized, double-blind clinical trial.

Setting and country:

The study site was an academic tertiary

hospital in Turkey

Funding and conflicts of interest:

H.C.Halhalli, Y. Yigit, O. Karakayali

and S. Yilmaz declare that they have no competing

interest.

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent was obtained from all individual

participants included in the study.

Inclusion criteria:

Adult patients aged 18 years and older; Patients with simple hand lacerations.

Exclusion criteria:

Patients with injuries to more than one body site; Patients with accompanying fractures; Patients with an incision length of more than 5 cm; Patients who had blunt injuries; Patients who had more than 12h prior to admission; Patients with injuries from animal and human bites; Patients with contaminated injuries; Patients who used antibiotics prior to admission (within 72h); Patients who had a disease that could have affected wound healing (diabetes mellitus, immune deficiency, transplantation, HIV/AIDS, and cancer); Patients who refused to give consent.

N total at baseline:

Intervention: N=109

Control: N=110

Important prognostic factors²:

Mean age

I: 36.44

C: 35.44

Sex:

I: 77/109 (70.6%) M

C: 75/110 (68.2%) M

Laceration length (cm):

I: 3.1 cm

C: 3.4 cm

Suturing (yes/no):

I: 18/89 (20.2%)

C: 21/89 (23.6%)

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

Oral 500 mg cephalexin monohydrate

Describe  control (treatment/procedure/test):

Wound cleaning with antiseptic and dressing in a blinded fashion.

Length of follow-up:

7 days

Loss-to-follow-up:

N=37 did not come to the control examination. The number of patients per treatment group were not further specified.

Wound infection, n/N (%)

Intervention I: 3/109 (2.7%)

Control: 2/110 (1.8%)

Adverse events, n/N (%)

Intervention I: 1/109 (0.9%) (nausea)

Control: 0/110 (0%)

Patient satisfaction, mean (95% C)

Intervention I: 92.5 (95% CI= 95% to 90.6 to 94.4)

Control: 94.6 (95% CI= 93 to 96.2)

Berwald, 2014

Type of study:

Randomized, double-blind, placebo-controlled pilot trial

Setting and country:

2 urban academic centers, USA

Funding and conflicts of interest:

None.

Inclusion criteria:

Patients with simple hand lacerations requiring repair (by sutures, staples, or tissue adhesives).

Exclusion criteria:

Immunocompromised patients; Current or recent use of any antibiotics; Gross infection as determined by the treating clinician; Grossly contaminated wounds by dirt or other foreign substances; Allergy to clindamycin or cephalexin; Bites; Crushed injuries; Lacerations inflicted more than 12 hours before ED visit; Pregnant or breast-feeding women; Diabetics.

N total at baseline:

I-1: N=25

I2: N=24

Control: N=24

Important prognostic factors²:

Median (IQR) age:

I1: 39 (26 to 56)

I2: 42 (32 to 58)

C: 40 (29 to 52)

P=0.851

Sex, n (%, 95% CI):

I: N=15 (60%, 41% to 77%)

I2: N=18 (75%, 55% to 88%)

C: N=19 (79%, 59% to 91%)

P=0.295

Length of the wound, median (IQR):

I1: 2 (2 to 2.5)

I2: 1.5 (1.25 to 2)

C: 2 (1.5 to 2.5)

P=0.222

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

I: Cephalexin 500 mg

II: Clindamycin 300 mg

Describe  control (treatment/procedure/test):

Placebo

Length of follow-up:

14 days

Satisfaction 30 days

Loss-to-follow-up:

Three patients were noncompliant and did not complete the medication

course (4%; 95% CI, 1%-11%) but they were analyzed in the same groups that they were allocated to.

Incomplete outcome data:

None.

Wound infection n/N (%, 95% CI)

Intervention: 0/49 (0%)

Control: 1/24 (4.2%)

Total: 1% (95% CI= 0.01 to 8%)

(minor) adverse events, n/N (%, 95% CI)

Intervention: 3/49 (6.1%)

Control: 1/24 (4.2%)

Total: 5% (95% CI= 2% to 13%)

(serious) adverse events, n/N (%, 95% CI)

No serious adverse events were reported.

Wound appearance satisfaction, median (IQR)

Total: 8 (9 to 10).

Altergott, 2008

Type of study:

Prospective randomized controlled trial

Setting and country:

Urban children’s hospital emergency department, USA.

Funding and conflicts of interest:

This study was supported in part by the National Institutes of Health,

National Center for Research Resources, and General Clinical Research

Center Grant MO1 RR00046 and was performed at the General Clinical

Research Center at Childrens Hospital Los Angeles. Computational

assistance was provided by the National Institutes of Health, National

Center for Research Resources, and General Clinical Research Center

Grant MO1 RR00046 and was performed at the General Clinical

Research Center at Childrens Hospital Los Angeles.

Inclusion criteria:

Patients aged <18 years; Patients presenting to the emergency department with a fingertip injury distal toe the distal interphalangeal joint.

Exclusion criteria:

Time from injury to repair greater than 8 hours; Patients with diabetes; Patients with an immune deficiency; Patients with a bleeding disorder; Patients who used steroids regularly; Patients presenting with a grossly contaminated wound; Patients who were currently taking antibiotics; Patients who had pevious allergic reactions to cephalosporins.

N total at baseline:

Intervention: N=66

Control: N=69

Important prognostic factors²:

Mean (SD) age:

I: 3.2 (2.9)

C: 3.0 (2.5)

Sex, n/N (%):

I: 34/66 (51.5%) M

C: 43/69 (62.3%) M

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

Cephalexin 50 mg/kg divided 3 times daily upon discharge for 7 days

Describe  control (treatment/procedure/test):

No antibiotics

Length of follow-up:

7 days

Loss-to-follow-up:

N=11

N=4 could not be reached for phone follow-up;

N=3 received antibiotics during the study period for a reason other than infection of the fingertip;

N=2 for whom insufficient data were available for analysis;

N=1 received antibiotics for repair;

N=1 requested to be withdrawn from the study before completion.

Subjects were equally distributed between the 2 groups: 6 (8%) of 75 from no-antibiotic group and 5 (7%) of 71 from antibiotic group (P = 1.0).

Wound infection, n/N (%)

At 7 days, a total of 7 patients had positive findings on phone follow-up (4 in the control group and 3 in the intervention group). These 7 patients returned to the emergency department for visual examination by one of the 3 primary investigators. One subject in each treatment group was found to have a true infection

Intervention: 1/66 (1.5%)

Control: 1/69 ( 1.4%)

Infection rate intervention= 1.52% (95% CI= 0.04$ to 8.16%)

Infection rate control= 1.45% (95% CI= 0.04% to 7.81%

P=1.000

After the completion of the study, chart review revealed 4 infections presenting beyond the 7-day window (days 7 to 14), 3 in the antibiotic group and 1 in the no-antibiotic group. Including these patients to the infected group brings the overall infection rate to 4.4%. Again, although the infection rate was lower in the group not treated with antibiotics (2.9% versus 6.1%), the difference was not statistically significant.

Intervention: 3/66 (4.5%)

Control: 1/69 (1.4%)

Overall infection rate= 4.4%

Study

First author, year

Appropriate and clearly focused question?

Yes/no/unclear

Comprehensive and systematic literature search?

Yes/no/unclear

Description of included and excluded studies?

Yes/no/unclear

Description of relevant characteristics of included studies?

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?

Yes/no/unclear/notapplicable

Assessment of scientific quality of included studies?

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?

Yes/no/unclear

Potential risk of publication bias taken into account?

Yes/no/unclear

Potential conflicts of interest reported?

Yes/no/unclear

Zehtabchi, 2007

Yes

Does the use of prophylactic antibiotics after repair of uncomplicated hand lacerations lead to a reduced incidence of wound infection?

Yes

The author searched the MEDLINE database with the OVID interface from 1966 to December 2005 and EMBASE from 1980 to December 2005, using search terms “wound,” “laceration,” “injury,” “hand,” “fingers,” “antibiotics,” “antibacterial agents,” and “prophylaxis.”. The MEDLINE search, but not other searches, was limited to randomized trials or systematic reviews using prophylactic antibiotics to prevent infection in hand lacerations. The author also scanned the databases of the Cochrane Library through 2005, Emergency Medical Abstracts1 from 1977 through December 2005, and online resources including BestBETS, using the search words “hand laceration,” “hand wound,” and “antibiotic prophylaxis.” He reviewed the bibliographies of the eligible trials for citations of additional eligible studies.

Yes

Yes

Table 1 summarizes the key features of the 4 trials. Two of the studies were conducted in EDs in the United States, and the other 29,10 were conducted in EDs in England. All 4 trials tested the use of prophylactic antibiotics for prevention of simple hand lacerations compared to a control group (placebo or no intervention). All excluded bite wounds and lacerations involving special structures, such as bone, nerve, large vessels, and tendons, and described a reasonable method of wound care (eg, irrigation and debridement) and closure technique (suturing) for all the study subjects

Not applicable

Yes

Unclear

Unclear

Unclear

Study reference

(first author, publication year)

Describe method of randomization¹

Bias due to inadequate  concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Berwald, 2014

Patients were randomized, using computer-generated block randomization, to 1 of 3 groups

Unlikely

Unlikely

Capsules were prepared by the research pharmacist and stored in coded bottles. All capsules were the same color and size. Investigators, subjects, and outcome assessors were blinded to the content of the capsules and bottles

Unlikely

Capsules were prepared by the research pharmacist and stored in coded bottles. All capsules were the same color and size. Investigators, subjects, and outcome assessors were blinded to the content of the capsules and bottles

Unlikely

Capsules were prepared by the research pharmacist and stored in coded bottles. All capsules were the same color and size. Investigators, subjects, and outcome assessors were blinded to the content of the capsules and bottles

Unlikely

All predefined outcome measures were reported

Unlikely

Three patients were noncompliant and did not complete the medication course (4%; 95% CI, 1%-11%) but they were analyzed in the same groups that they were allocated to.

Unlikely

Intention-to-treat analysis was observed during group comparisons

Halhalli, 2018

The patients were allocated in a 1:1:1 ratio to receive an oral 500 mg cephalexin monohydrate (Sef; Mustafa Nevzat İlaç San, İstanbul, Turkey) or topical pomade including 2% mupirocin (Bactroban; Glaxo Smith Kline, İstanbul, Turkey), or wound cleaning with antiseptic and dressing in a blinded fashion The randomization schedule was generated with http://www.randomization.com.

Unlikely

The randomization number generated by the responsible investigator using www.randomization.com was determined for the patient. The responsible investigator then telephoned the supervising nurse and relayed the patient’s randomization number

Unlikely

The senior emergency medical resident in charge of patient care and the emergency medical specialist in charge of the control examination were blinded to the implemented treatment; the statistician was also blinded to treatment allocation during statistical analyses.

Unlikely

The senior emergency medical resident in charge of patient care and the emergency medical specialist in charge of the control examination were blinded to the implemented treatment; the statistician was also blinded to treatment allocation during statistical analyses.

Unlikely

The senior emergency medical resident in charge of patient care and the emergency medical specialist in charge of the control examination were blinded to the implemented treatment; the statistician was also blinded to treatment allocation during statistical analyses.

Unlikely

All predefined outcome measures were reported

Unclear

37 patients did not come to the control examination.

Not further specified

Unlikely

An intention-to-treat analysis was performed to avoid overestimation of clinical effectiveness. All randomized patients were included in the statistical analysis regardless of the treatment implemented and regardless of the withdrawal status of the patient

Altergott, 2008

Participants were randomized to 1 of 2 groups using a randomization list prepared in advance with PROC PLAN within the Statistical Analysis System

Likely

Patient enrollment was at the discretion of the emergency department attending physician working at the time of repair. He or she may have been reluctant to enroll more complicated fingertip lacerations (ie, complete avulsions) or may have been too busy or distracted to enroll all eligible patients.

Unclear

Blinding in relation to treatment allocation not described.

Unclear

Blinding in relation to care providers not described.

Likely

Follow-up was not blinded. This could have introduced bias in the reporting of infection

Unlikely

All predefined outcome measures were reported

Unlikely

Eleven participants were withdrawn before study completion. Those not completing the study included 4 subjects who could not be reached for phone follow-up, 3 subjects who received antibiotics during the study period for a reason other than infection of the fingertip, 2 subjects for whom insufficient data were available for analysis, 1 subject who received antibiotics before repair, and 1 subject who requested to be withdrawn from the study before completion. These 11 subjects were significantly older than those who completed the study (6.0 T 3.8 years versus 3.1 T 2.7 years; P = 0.001) but were similar on all other baseline characteristics. In addition, subjects were equally distributed between the 2 groups: 6 (8%) of 75 from no-antibiotic group and 5 (7%) of 71 from antibiotic group (P = 1.0).

Unlikely