Trials / Completed
CompletedNCT03274466
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
Post-market, Randomized, Open-Label, Multicenter, Study to Evaluate the Effectiveness of Closed Incision Negative Pressure Therapy Versus Standard of Care Dressings in Reducing Surgical Site Complications in Subjects With Revision of a Failed Total Knee Arthroplasty (PROMISES)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 294 (actual)
- Sponsor
- KCI USA, Inc · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.
Conditions
- Surgical Wound
- Revision Total Knee Arthroplasty
- Wounds and Injuries
- Joint Disease
- Musculoskeletal Disease
- Prosthesis-Related Infections
- Infection
- Postoperative Complications
- Pathologic Processes
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Closed Incision Negative Pressure Therapy (ciNPT) | Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days. |
| DEVICE | Standard of Care Dressing | A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively. |
Timeline
- Start date
- 2017-12-05
- Primary completion
- 2019-11-27
- Completion
- 2019-12-19
- First posted
- 2017-09-07
- Last updated
- 2024-10-16
- Results posted
- 2021-02-10
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03274466. Inclusion in this directory is not an endorsement.