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PICO- Single-use Negative Pressure Wound Therapy System

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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 details

Total Ankle Arthroplasty

NCT05064696

Walter C Hembree

25 January 2024

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