CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 122 enrolled
Drug / intervention
Prevena +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03061903
NCT03061903N/ACompleted

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

Columbia University·interventional·Posted Feb 23, 2017·Updated Apr 11, 2023

In Brief

A clinical study evaluating Prevena and Aquacel for Wound Complication. Completed, enrolled 122 participants across 3 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartMay 14, 2018
Primary CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.4 years ago

Interventions

Prevenadevice

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. Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.

Aquaceldevice

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.