Wynne 2004.
| Methods | 3‐arm RCT undertaken in Australia | |
| Participants | People having cardiac surgery that required a median sternotomy incision Exclusion criteria: immunosuppressed and non‐consenting people, and those under the care of surgeons who were not participating in the study |
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| Interventions | Group A (n = 243): dry absorbent dressing (Primapore, Smith & Nephew) removed on day 2 postoperatively Group B (n = 267): hydrocolloid dressing (DuoDerm Thin, ConvaTec) in situ for 5 days Group C (n = 227): film dressing (Opsite, Smith & Nephew) in situ for 5 days | |
| Outcomes | Primary review outcome: SSI (definition of infection based on CDC guidelines for prevention of surgical site infection. Infection defined as superficial (involving skin and subcutaneous tissues), or deep (involving muscle, bone and mediastinum), in conjunction with one of the following: excision of wound tissue, a positive wound culture or treatment with antibiotics) Secondary review outcomes: cost (median per participant); acceptability (assessed by participants); ease of removal: (discomfort with removal ‐ assessed by participants). Scarring and pain not reported. |
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| Notes | Trial outcome data: see Table 12 Follow‐up: outcome data collected daily on days 1‐5 postoperatively. Subsequent follow‐up via outpatient clinic, or phone call 4 weeks after discharge. At 4 weeks participants were questioned about their experiences with regard to pain, tenderness, redness, swelling, discharge or oozing from the chest wound; and whether they had sought medical attention or had antibiotic therapy initiated by doctor. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to one of the three treatments by the circulating nurse on the commencement of sternal skin closure". |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was stratified equally across two operating theaters and was achieved using opaque envelopes". |
| Blinding (performance bias and detection bias) All outcomes | High risk | Participants: not stated Personnel: not stated Outcome assessors: quote: "Blinding of data collectors to treatment was not feasible ...". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | SSI: denominator values suggested complete follow‐up for short‐term period. |
| Selective reporting (reporting bias) | Low risk | Given the information presented in the paper, all prespecified outcomes reported. |
| Other bias | Unclear risk | Varied timings as well as dressing types. |
Abbreviations
< = less than > = more than CDC = Centers for Disease Control and Prevention EQ‐5D = EuroQol five dimensions questionnaire (a standardised instrument for measuring generic health status) GI = gastrointestinal ITT = intention‐to‐treat (analysis) n = number in group PHMB = PI = principal investigator RAND = RCT = randomised controlled trial SAS = statistical analysis system SSI = surgical site infection THR = total hip replacement TKR = total knee replacement VAS = visual analogue scale vs = versus