Infection, Drainage Clinical Trial
Official title:
Comparison of Negative Pressure Wound Therapy Versus Conventional Dressings for the Prevention of Wound Complications Following Revision Total Hip Arthroplasty: A Prospective, Randomized, Controlled Trial
| Verified date | June 2024 |
| Source | Rush University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.
| Status | Active, not recruiting |
| Enrollment | 201 |
| Est. completion date | November 1, 2024 |
| Est. primary completion date | March 14, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients > 18 years of age undergoing a revision total hip arthroplasty procedure to include: - Conversion of a prior open hip surgery (i.e. open reduction internal fixation of a proximal femur fracture) to a total hip arthroplasty - Aseptic revision for a diagnosis of component loosening, osteolysis, or revision procedure for periprosthetic fracture that requires revision of a component of the THA prosthesis (excluded isolated open reduction internal fixation of the fracture or initial placement of a hemi- or total hip arthroplasty) - Septic revision surgery including irrigation and debridement of a postoperative infection or hematoma, one-stage exchange for acute postoperative infection, explantation and placement of an antibiotic cement spacer - Reimplantation of a THA following placement of an antibiotic-loaded cement spacer - The incision can be closed primarily without muscle flaps or skin grafting - Willingness to undergo randomization and return for all scheduled visits Exclusion Criteria: - Patients requiring a muscle flap or skin grafting for wound closure - Pregnant or lactating female - Known sensitivity to the study product components (adhesives, etc.) - Allergy to silver |
| Country | Name | City | State |
|---|---|---|---|
| United States | Anne DeBenedetti | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rush University Medical Center | 3M |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wound complications | Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions (i.e. unplanned office visits, topical application of antibiotics or PO antibiotics, in-office wound debridement or removal of suture material, hematoma aspiration and drainage) or a return to the operating room/reoperation. | 90 days | |
| Secondary | Reoperation | Reoperation for a wound complication, surgical site infection, or periprosthetic joint infection within 90 days of the revision THA | 90 days | |
| Secondary | Cost comparison | Cost comparison between the NPWT and routine dressing changes within 90 days to include the potential costs of postoperative interventions and reoperation | 90 days |