PICO- Single-use Negative Pressure Wound Therapy System

Not Applicable

Recruiting

• Conditions: Total Ankle Arthroplasty
• Interventions: Other: Non-stick gauze dressing; Device: PICO dressing

• Registration Number: NCT05064696
• Lead Sponsor: Walter C Hembree

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.

Detailed 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.

Study Timeline

• Study Start: 2021-08-25
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Control group)	Non-stick gauze dressing	Surgical wound will be covered with the standard non-stick gauze dressing.
Group 2 (Treatment group)	PICO dressing	Surgical wound will be covered with the PICO dressing.

Primary Outcome Measures

Name	Time	Method
Wound complications	Approximately 12-weeks after surgery (or until 3-month postop visit is completed)	To determine presence or absence of wound complications at the follow-up visits.

Trial Locations

Locations (1)

Amy Loveland; 🇺🇸 Baltimore, Maryland, United States