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N/A N=122 Randomized Prevention

Closed Incision Negative Pressure Therapy vs Standard of Care

Wound Complication

Enrolled (actual)
122
Serious AEs
0.8%
Results posted
Apr 2023
Primary outcome: Primary: Prevalence of Wound Complications — 5; 11 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prevena (Device); Aquacel (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Columbia University
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Prevalence of Wound Complications
5; 11
SECONDARY
Number of Patients With Superficial Surgical Site Infections
2; 9

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03061903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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