Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound … (NCT03321799) | Clinical Trial Compass
CompletedPhase 1
Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA
United States201 participantsStarted 2017-04-28
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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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