PICO- Single-use Negative Pressure Wound Therapy System

Walter C Hembree

Status: Enrolling

Conditions: Total Ankle Arthroplasty

Treatments: Other: Non-stick gauze dressing; Device: PICO dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05064696

STUDY00003790

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group 1 (Control group)

Active Comparator group

Description:

Surgical wound will be covered with the standard non-stick gauze dressing.

Treatment:

Other: Non-stick gauze dressing

Group 2 (Treatment group)

Experimental group

Description:

Surgical wound will be covered with the PICO dressing.

Treatment:

Device: PICO dressing