Pachowsky 2012.
Methods |
Study design: randomised controlled trial
Ethics and informed consent: ethics approved and consent obtained. Sample size calculation: no ITT analysis: yes number randomised: 19 number analysed: 19 Follow‐up period: 10 days Funding: support received from Smith & Nephew. The authors were responsible for trial design, data analysis, and manuscript writing. The decision to publish trial results was made between study authors and study sponsors. Pre‐registration: no |
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Participants |
Location: University Hospital Erlangen, Germany Intervention group: n = 9control group: n = 10 Mean age: intervention group = 66.2 years (SD 17.83)control group = 70.0 years (SD 11.01) Inclusion criteria: "consecutive patients who were scheduled for a total hip arthroplasty (THA) for osteoarthritis of the hip were randomised" Exclusion criteria: not stated |
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Interventions |
Aim/s: to evaluate the use of NPWT to improve wound healing after total hip arthroplasty
Intervention/s in both groups: "the surgical intervention was identical for both groups. All patients received two Redon drains, one in the deep area of the wound close to the prostheses and one above the closed fascia. The postoperative physiotherapy and mobilisation was also identical for both groups. Both groups received perioperative prophylaxis with antibiotics either Augmentin (amoxicillin trihydrate with potassium clavulanate) or ciprofloxacin" Group 1 (NPWT) intervention: "the NPWT group was treated with a PREVENA™ system (KCI, San Antonio, USA). The PREVENA system was left on the wound for five days including the day of surgery" Group 2 control: the control group received "the standard wound dressing of our department, consisting of a dry wound coverage". Study date/s: not stated |
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Outcomes |
Validity of measure/s: "all patients underwent an ultrasound (Zonare, Z.one Ultra SP 4.2, Erlangen, ZONARE Medical Systems, Inc., Mountain View, USA) of the wound" Time points: day 5 and day 10 of postoperative period |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Evidence for participants: not possible Comment: unlikely to affect outcomes Evidence for personnel: not possible Comment: unlikely to affect outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Dressings were left in place for 5 days. The ultrasound was performed on day 5. It was unclear if the person performing the ultrasound was aware of the group to which the participant had been allocated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All enrolled participants were accounted for in the analyses. |
Selective reporting (reporting bias) | Low risk | Results for outcomes identified in the methods section were reported. We did not see the original protocol. |
Other bias | High risk |
Evidence: quote: "Matthias H. Brem gave scientific presentations for KCI. The PREVENA wound treatment system was provided by KCI free of charge". Support was received from Smith & Nephew. The authors were responsible for trial design, data analysis, and manuscript writing. The decision to publish trial results was made between study authors and study sponsors. 1 participant in the NPWT group removed the Redon drain by himself on the first postoperative day. |