PICO- Single-use Negative Pressure Wound Therapy System
NCT05064696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-09-21
Summary
To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.
Conditions
- Total Ankle Arthroplasty
Interventions
- OTHER
-
Non-stick gauze dressing
Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
- DEVICE
-
PICO dressing
Group 2 (Treatment group): surgical site will be dressed with PICO dressing
Sponsors & Collaborators
-
Smith & Nephew, Inc.
collaborator INDUSTRY -
Walter C Hembree
lead OTHER
Principal Investigators
-
Walter C Hembree, MD · MedStar Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-25
- Primary Completion
- 2024-09-30
- Completion
- 2025-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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