Randomized Controlled Clinical Trial for Closed Incision Negative Pressure Wound Therapy (NPWT) Devices in Total Knee Arthroplasty (TKA)
| Registry | NCT07770633 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 300 (Estimated) |
| Sponsor | The Cleveland Clinic (Other); collaborators: Stryker Instruments |
| Conditions | Wound Surgical, Diabetes, Obesity, Chronic Kidney Diseases, Smoking |
| Interventions | NP Seal, PICO, Prevena (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2029-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-08-18, last updated 2026-09-25 |
Related Papers Related Patents Related Grants Related Experts
All trials for Wound Surgical All trials for Diabetes All trials of NP Seal All trials of PICO
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| NP Seal | Active comparator | Device: NP Seal | NP Seal is a single-use negative pressure dressing with an integrated mechanical pinch pump. It is applied over the closed incision. |
| PICO dressing | Active comparator | Device: PICO | PICO is a single-use negative pressure dressing connected to a small portable pump. |
| Prevena dressing | Active comparator | Device: Prevena | Prevena is a closed-incision negative pressure dressing connected to a portable therapy unit. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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