Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty

NCT07770633 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-462
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Surgical complications

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

  From day of surgery to 90days post-op

Secondary Outcomes (2)

• Patient Post-Operative Dressing Survey

  From day of surgery to 90days post-op

• Provider Assessment Survey

  From day of surgery to 90days post-op

Study Arms (3)

NP Seal

ACTIVE COMPARATOR

NP Seal is a single-use negative pressure dressing with an integrated mechanical pinch pump. It is applied over the closed incision.

Device: NP Seal

PICO dressing

ACTIVE COMPARATOR

PICO is a single-use negative pressure dressing connected to a small portable pump.

Device: PICO

Prevena dressing

ACTIVE COMPARATOR

Prevena is a closed-incision negative pressure dressing connected to a portable therapy unit.

Device: Prevena

Interventions

NP Seal DEVICE

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

NP Seal

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

PICO dressing

Prevena DEVICE

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

Prevena dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prisoners
• Pregnant women
• Patients who indicate they may not comply with post-operative instructions
• Patients with active bleeding

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Stryker Instruments: collaborator

MeSH Terms

Conditions

Surgical Wound; Diabetes Mellitus; Obesity; Renal Insufficiency, Chronic; Smoking

Condition Hierarchy (Ancestors)

Wounds and Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Behavior

Central Study Contacts

Nicolas Piuzzi, MD

CONTACT

216-445-9109; piuzzin@ccf.org

Brittany McKnight, BA

CONTACT

440-262-0318; mcknigb@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09