PICO- Single-use Negative Pressure Wound Therapy System
Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2021
CompletedFirst Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedSeptember 21, 2023
September 1, 2023
3.1 years
September 22, 2021
September 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound complications
To determine presence or absence of wound complications at the follow-up visits.
Approximately 12-weeks after surgery (or until 3-month postop visit is completed)
Study Arms (2)
Group 1 (Control group)
ACTIVE COMPARATORSurgical wound will be covered with the standard non-stick gauze dressing.
Group 2 (Treatment group)
EXPERIMENTALSurgical wound will be covered with the PICO dressing.
Interventions
Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
Group 2 (Treatment group): surgical site will be dressed with PICO dressing
Eligibility Criteria
You may qualify if:
- Patient ≥18 years old
- Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty
- Subjects able to provide informed consent
- Subjects who are able to understand and comply with study visit schedule and procedures
You may not qualify if:
- History of previous deep infection or history of wound complication necessitating plastic surgery intervention
- Allergy to products used in the study
- Pregnant and breastfeeding women due to anesthesia risks
- Subjects with a known history of poor compliance with medical treatment
- Subjects who decline participation in this research study
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Walter C Hembreelead
- Smith & Nephew, Inc.collaborator
Study Sites (1)
Amy Loveland
Baltimore, Maryland, 21218, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Walter C Hembree, MD
MedStar Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 1, 2021
Study Start
August 25, 2021
Primary Completion
September 30, 2024
Study Completion
September 30, 2025
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share