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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05064696
Other study ID # STUDY00003790
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2021
Est. completion date September 30, 2025

Study information

Verified date September 2023
Source Medstar Health Research Institute
Contact Amy Loveland
Phone 301-560-2937
Email amy.loveland@medstar.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participating subjects will be randomized to one of the study groups: Group 1 (Control group) or Group 2 (Treatment group). If randomized to Group 1- after surgery, the doctor will apply the standard non-stick gauze dressing to the wound. If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound. The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Amy Loveland Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Walter C Hembree Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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