PICO- Single-use Negative Pressure Wound Therapy System

Sponsor

Walter C Hembree (Other)

Overall Status

Recruiting

CT.gov ID

NCT05064696

Collaborator

Smith & Nephew, Inc. (Industry)

150

Enrollment

Location

Arms

49.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Ankle Arthroplasty	Other: Non-stick gauze dressing Device: PICO dressing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing

Actual Study Start Date :

Aug 25, 2021

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Wound complications [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amy Loveland	Baltimore	Maryland	United States	21218

Sponsors and Collaborators

Walter C Hembree
Smith & Nephew, Inc.

Investigators

Principal Investigator: Walter C Hembree, MD, MedStar Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walter C Hembree, MD, Medstar Health Research Institute

ClinicalTrials.gov Identifier:

NCT05064696

Other Study ID Numbers:

STUDY00003790

First Posted:

Oct 1, 2021

Last Update Posted:

Jun 3, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Walter C Hembree, MD, Medstar Health Research Institute

Total ankle arthroplasty

Study Results

No Results Posted as of Jun 3, 2022