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 |
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Interventions | Intervention: Chloramphenicol 1% ointment applied immediately after wound closure and on day 3 Control: no ointment applied. |
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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 |
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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. |