Closed Incision Negative Pressure Therapy vs Standard of Care
Completed · Not applicable
Conditions studied: Wound Complication
In brief
High risk patients who receive direct anterior approach total hip arthroplasty are more likely to experience wound complications. The purpose of this study is to determine whether the usage of closed incision negative pressure dressings decreases the risk of wound complication compared to standard dressings. Patients who decide to participate in the study will be randomized to one of the two dressing prior to surgery and will leave the operating room with one of the treating dressings. Patient will be monitored 90 days after surgery for wound complications and pictures of the wounds will be taken. The patients course of treatment besides being randomized to one of the two dressings will be identical to any other patient received a Direct Anterior Approach for Total Hip Arthroplasty (DAA THA). The primary outcome measure will be uneventful wound healing (requiring no intervention) versus the occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound). Secondary outcome measures will include duration of wound healing delay, length of hospital stay, number of days of antibiotic therapy, and direct and estimated indirect costs.
Key facts
- Study ID
- NCT03061903
- Run by
- Columbia University
- People needed
- 122
- Starts
- 2018-05-14
- Expected to finish
- 2022-03-07
- Last updated by the study team
- 2023-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing primary total hip arthroplasty (THA) through a direct anterior approach by one of the investigating surgeons; and
- The presence of one or more of these risk factors for delayed or problematic wound healing:
- Diabetes
- Obesity (Body Mass Index (BMI) > 30)
- Active smoking
- Previous Hip Surgery
You may not qualify if…
- Patients undergoing primary THA through a different approach
- Patients undergoing primary THA through a direct anterior approach but without any of the above risk factors
Where it is running
- Hospital for Special Surgery — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Humber River Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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