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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.