PICO- Single-use Negative Pressure Wound Therapy System

Purpose

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

Condition

  • Total Ankle Arthroplasty

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group 1 (Control group) 		Surgical wound will be covered with the standard non-stick gauze dressing.
  • Other: Non-stick gauze dressing
    Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
Experimental
Group 2 (Treatment group) 		Surgical wound will be covered with the PICO dressing.
  • Device: PICO dressing
    Group 2 (Treatment group): surgical site will be dressed with PICO dressing

Recruiting Locations

Amy Loveland
Baltimore, Maryland 21218
Contact:
Amy Loveland
301-560-2937
amy.loveland@medstar.net

More Details

Status
Recruiting
Sponsor
Walter C Hembree

Study Contact

Amy Loveland
301-560-2937
amy.loveland@medstar.net

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.