Trials / Terminated
TerminatedNCT04712019
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
A Randomized Controlled Trial Evaluating Edema and ROM Using Negative Pressure Therapy Over Closed Incisions and Surrounding Soft Tissue Versus Standard Surgical Dressings in Bilateral Total Knee Arthroplasty: A Pilot Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Solventum US LLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
Conditions
- Surgical Wound
- Bilateral Total Knee Arthroplasty
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Edema Leg
- Joint Pain
- Arthritis Knee
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 at 125mmHg of continuous negative pressure on a closed surgical incision |
| DEVICE | Standard Silver-containing Dressing | A standard silver-containing dressing applied to a closed surgical incision |
Timeline
- Start date
- 2020-11-06
- Primary completion
- 2022-08-26
- Completion
- 2022-08-26
- First posted
- 2021-01-15
- Last updated
- 2024-10-01
- Results posted
- 2024-05-01
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04712019. Inclusion in this directory is not an endorsement.