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. 2016 Nov 7;2016(11):CD011426. doi: 10.1002/14651858.CD011426.pub2

Kamath 2005.

Methods 2‐arm, blinded RCT. Clean/contaminated (class 2) surgery
Participants 100 participants with a fractured neck of femur enrolled. 1 participant was excluded after randomisation due to confirmed metastatic disease and 7 participants died before completion of the trial.
Exclusion criteria: pathological fractures, undisplaced intracapsular neck of femur fractures requiring internal fixation
Setting: orthopaedic hospital inpatients at a District General Hospital, UK
Interventions Intervention: Chloramphenicol 1% ointment applied immediately after wound closure and on day 3
Control: no ointment applied.
Outcomes SSI (dichotomous); adverse effects (dichotomous); wound healing (dichotomous)
Notes 1 participant excluded for confirmed metastatic disease, 7 participants died before completion of trial.
Definition of SSI: presence of Scottish Centre for Infection and Enrinomental Health guidelines for SSI surveillance
Definition of adverse effects: not defined ‐ participants who developed chest infections, urinary tract infections and positive wound swab results were included.
Definition of wound healing: number of wounds not healed at 30 days
Concurrent illness: rheumatoid arthritis, diabetes mellitus, systemic medical condition unspecified, smoker
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: study was reported as randomized but method of random sequence generation was not reported.
Allocation concealment (selection bias) Low risk Quote: "All the cases once included in the study were randomized in an opaque sealed envelope, which was opened at the end of the surgical procedure."
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "All observations were done by one tissue viability nurse, who was blinded as to the treatment group of patients."
Comment: participants were likely aware of allocation (ointment vs no ointment).
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: outcome assessor was blinded; participants were not. Outcomes measured were unlikely to be affected by blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: data not reported for all enrolled participants; 7 died during study and 1 participant was excluded due to morbidity. Outcome data were not recorded in these 8 subjects, who constituted 8/100 (8%) of the participants, but their allocated groups were not specified. ITT analysis was not performed.
Selective reporting (reporting bias) Unclear risk Comment: outcome data were presented for all outcomes listed in methods. Study protocol was not available for identification of any unreported outcomes.
Other bias Low risk Comment: none were identified.