PICO- Single-use Negative Pressure Wound Therapy System

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

To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

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.

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