Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complications; Arthroplasty, Infection or Inflammation
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Mean Wound Healing Scores by the ASEPSIS Criteria
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients undergoing primary total hip arthroplasty.
Exclusion Criteria
- •age less than 18 y/o
- •Total hip arthroplasty for fracture
- •Revision or conversion total hip arthroplasty
- •inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- •multiple surgical procedures
- •Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
- •skin hypersensitivity to acrylic adhesive or silver.
- •Inability to care for dressing due to physical or mental incapacitation
Outcomes
Primary Outcomes
Mean Wound Healing Scores by the ASEPSIS Criteria
Time Frame: (Single point evaluation)-2 weeks post surgery visit
A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.
Secondary Outcomes
- Number of Participants With Infection((Single point evaluation)-6 weeks post surgery visit)