Clinical Trial

Wound Complications in High-Risk Hip Replacement Patients

Study Description

Closed Incision Negative Pressure Therapy vs Standard of Care

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Device - Prevena

Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days. Prevenaâ„¢, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.

Device - Aquacel

Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days. AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.

Additional Information

Official Study Title

Closed Incision Negative Pressure Therapy vs. Standard of Care for Surgical Incision Management in High-Risk Patients Following Total Hip Arthroplasty: A Randomized Controlled Trial

Clinical Trial ID

NCT03061903

ParticipAid ID

NbW0vd