Status:
COMPLETED
Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
3M
Conditions:
Infection, Drainage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized contro...
Detailed Description
Wound complications and surgical site infections (SSI) following revision total joint arthroplasty result in significant morbidity and cost. Persistent incisional drainage following total joint arthro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2025
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03321799
Start Date
April 28 2017
End Date
July 11 2025
Last Update
August 6 2025
Active Locations (1)
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1
Anne DeBenedetti
Chicago, Illinois, United States, 60607