Clinical trial

Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty

Opening soon · Not applicable · 0 countries · Registry ID NCT07770633

Opening soonNot applicableInterventional

What this study is about

This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications. A total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery. The primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance. Research-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and/or dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation. This study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionWound Surgical, Diabetes, Obesity, Chronic Kidney Diseases, Smoking

Full registry criteria

Inclusion Criteria: * Age 18 years or older * Undergoing primary total knee arthroplasty * Able to understand the study, provide informed consent, and participate in study procedures Meet at least one of the following co-morbidities: * BMI ≥35 * Diabetes * Prior surgical incision(s) in the operative area * Chronic kidney disease Exclusion Criteria: * Prisoners * Pregnant women * Patients who indicate they may not comply with post-operative instructions * Patients with active bleeding

Treatments and study arms

NP Seal

Device

Designed to maintain negative pressure without an external battery-powered pump or canister.

PICO

Device

Designed to deliver negative pressure for up to 7 days and has visual alerts for issues such as air leaks, low battery, or dressing change

Prevena

Device

Designed to deliver continuous negative pressure over the closed incision and collect fluid in a separate canister.

Primary outcomes

Surgical complicationsFrom day of surgery to 90days post-op

Incidence of 90-day surgical site complications among patients receiving NPseal, PICO, or Prevena dressings.

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.