PICO- Single-use Negative Pressure Wound Therapy System

Study Overview
=================
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.

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

Conditions
-----------------
Total Ankle Arthroplasty

Intervention / Treatment
-----------------
* Other: Non-stick gauze dressing
* Device: PICO dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Control group)<br>Surgical wound will be covered with the standard non-stick gauze dressing. | Other: Non-stick gauze dressing<br>* Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing<br>|
| Experimental: Group 2 (Treatment group)<br>Surgical wound will be covered with the PICO dressing. | Device: PICO dressing<br>* Group 2 (Treatment group): surgical site will be dressed with PICO dressing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total ankle arthroplasty, PICO, Ankle, Ankle joint, Arthroplasty