PICO Dressing for Total Ankle Replacement Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is the PICO dressing generally safe for use in humans?
How is the PICO dressing treatment different from other treatments for total ankle replacement recovery?
The PICO dressing is a unique treatment because it uses negative pressure wound therapy (NPWT) to help heal surgical wounds by reducing complications like infections and wound dehiscence (wound reopening). It is a portable, single-use system that requires fewer dressing changes compared to traditional methods, making it more convenient for outpatient care.12345
What data supports the effectiveness of the PICO dressing treatment for total ankle replacement recovery?
Research shows that the PICO dressing, a type of negative pressure wound therapy, has been effective in reducing complications like infections and wound reopening in various surgeries, including lower extremity amputations. This suggests it may help improve recovery after total ankle replacement by promoting better wound healing.12345
Who Is on the Research Team?
Walter C Hembree, MD
Principal Investigator
MedStar Health
Are You a Good Fit for This Trial?
This trial is for adults over 18 who can consent to participate, understand the study's procedures, and are having a total ankle replacement or revision. It's not for those with allergies to study products, past deep infections or wound issues requiring plastic surgery, pregnant or breastfeeding women, people with poor medical treatment compliance history, prisoners.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo anterior total ankle arthroplasty and receive either a standard non-stick gauze dressing or a PICO dressing
Follow-up
Participants are monitored for wound complications and assessed through follow-up visits
What Are the Treatments Tested in This Trial?
Interventions
- PICO dressing
PICO dressing is already approved in United States, European Union, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Walter C Hembree
Lead Sponsor
Smith & Nephew, Inc.
Industry Sponsor
Dr. Maria Berkman
Smith & Nephew, Inc.
Chief Medical Officer since 2023
MD from Harvard Medical School
Dr. Deepak Nath
Smith & Nephew, Inc.
Chief Executive Officer since 2022
PhD in Theoretical Mechanics, University of California, Berkeley