PICO- Single-use Negative Pressure Wound Therapy System

Total Ankle Arthroplasty Clinical Trial

Official title:

Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064696
• Other study ID #: STUDY00003790
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Ankle Arthroplasty

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)