Recruiting

Negative Pressure Wound TherapyPICO- Single-use Negative Pressure Wound Therapy System

Sponsor:

Walter C Hembree

Code:

NCT05064696

Conditions

Total Ankle Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-stick gauze dressing

PICO dressing

Study Details

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.

Conditions

Total Ankle Arthroplasty

Study ID

NCT05064696

Start date

Aug 25, 2021

Status verified date

Sep, 2023

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group 1 (Control group)

Surgical wound will be covered with the standard non-stick gauze dressing.

experimental: Group 2 (Treatment group)

Surgical wound will be covered with the PICO dressing.

Interventions

Non-stick gauze dressing

Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing

PICO dressing

Group 2 (Treatment group): surgical site will be dressed with PICO dressing

Primary outcome measure

Wound complications [ Time Frame: Approximately 12-weeks after surgery (or until 3-month postop visit is completed) ]

Central Contacts and Locations

Central contacts

Amy Loveland

301-560-2937 amy.loveland@medstar.net

Crisanto Macaraeg

410-261-8218 Crisanto.L.Macaraeg@Medstar.net

Locations

Amy Loveland

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Amy Loveland

301-560-2937 amy.loveland@medstar.net

Crisanto Macaraeg

410-261-8218 Crisanto.L.Macaraeg@Medstar.net

Principal Investigator:

Walter C. Hembree, MD

More Information

Sponsor

Walter C Hembree

Last update posted

Sep 21, 2023

Last verified

Sep, 2023

Keywords

Total ankle arthroplasty
PICO
Ankle
Ankle joint
Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter C Hembree on 2023-09-21.