Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty

Sponsor
The Cleveland Clinic
Study ID
NCT07770633
Status
Not Yet Recruiting

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Conditions

  • Chronic Kidney Diseases
  • Diabetes
  • Obesity
  • Smoking
  • Wound Surgical

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NP Seal
    NP Seal is a single-use negative pressure dressing with an integrated mechanical pinch pump. It is applied over the closed incision.
  • Active Comparator: PICO dressing
    PICO is a single-use negative pressure dressing connected to a small portable pump.
  • Active Comparator: Prevena dressing
    Prevena is a closed-incision negative pressure dressing connected to a portable therapy unit.

Primary Outcome Measure

Surgical complications [ Time Frame: From day of surgery to 90days post-op ]

Central Contacts

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