PICO- Single-use Negative Pressure Wound Therapy System

September 20, 2023 updated by: Walter C Hembree

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Amy Loveland
        • Principal Investigator:
          • Walter C. Hembree, MD
        • Sub-Investigator:
          • Stuart Miller, MD
        • Sub-Investigator:
          • Gregory Guyton, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complications
Time Frame: Approximately 12-weeks after surgery (or until 3-month postop visit is completed)
To determine presence or absence of wound complications at the follow-up visits.
Approximately 12-weeks after surgery (or until 3-month postop visit is completed)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter C Hembree

Collaborators

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Walter C Hembree, MD, MedStar Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00003790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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