NCT05064696

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Walter C Hembree · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Total Ankle Arthroplasty

Interventions

Type	Name	Description
OTHER	Non-stick gauze dressing	Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
DEVICE	PICO dressing	Group 2 (Treatment group): surgical site will be dressed with PICO dressing

Timeline

• Start date: 2021-08-25
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2021-10-01
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study