Routine Use of Negative Pressure Wound Therapy THR TKR RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorChinese University of Hong Kong
About this trial
Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.
Disqualifiers
Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.
Trial design
Design model
Parallel
Treatments tested in this trial
negative pressure wound therapy
DeviceThe intervention group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility.
standard dressing
Other interventionThe standard dressing group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The same PICO dressing will be applied, but without the suction.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: negative pressure wound therapyExperimental treatment 1 intervention
Group B: standard dressingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound-related complications
Recurrence of wound exudate, surgical site infections, dressing-related issues, readmission to hospital and any further surgical interventions will be documented by the research personnel status at 21 days after the index operation.
Time frame
21 days after surgerySecondary outcomes
1
Patient Scale and Observer Scale (POSAS)
The POSAS has category boxes to core nominal parameters, for example colour of the scar. Each item of both scales have a 10-point score, with 10 indicating the worse imaginable scar or sensation and 1 corresponding to normal scar or skin (normal pigmentation, no itching, etc.). The total score of both scale is calculated by summing up the score of each of the six items and ranges from 6 to 60.
Time frame
21 days after surgery2
Multi-category visual analogue scale
The multi-category visual analogue scale (VAS) is a photograph based scale derived from evaluating standardised digital photographs in four categories (pigmentation, vascularity, acceptability and patient comfort) plus contour. The individual scores are added to give a single overall score ranging from "excellent" to "poor"
Time frame
21 days after surgerySponsors and contacts
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Source ClinicalTrials.gov