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Negative Pressure Wound Therapy System

PICO Dressing for Total Ankle Replacement Recovery

N/A

Recruiting

Led By Walter C Hembree, MD

Research Sponsored by Walter C Hembree

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be 18 years old or older

Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12-weeks after surgery (or until 3-month postop visit is completed)

Awards & highlights

Study Summary

This trial compares the rate of wound complications between the PICO dressing and a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

Who is the study for?

This trial is for adults over 18 who can consent to participate, understand the study's procedures, and are having a total ankle replacement or revision. It's not for those with allergies to study products, past deep infections or wound issues requiring plastic surgery, pregnant or breastfeeding women, people with poor medical treatment compliance history, prisoners.Check my eligibility

What is being tested?

The trial is testing if a PICO dressing—a single-use negative pressure therapy system—reduces wound complications better than standard non-stick gauze after total ankle arthroplasty (ankle replacement surgery).See study design

What are the potential side effects?

While specific side effects aren't listed here, typical concerns may include skin irritation from the dressings or an allergic reaction in sensitive individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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I am having or have had a total ankle replacement or a simple revision of one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12-weeks after surgery (or until 3-month postop visit is completed)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12-weeks after surgery (or until 3-month postop visit is completed)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12-weeks after surgery (or until 3-month postop visit is completed) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Wound complications

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2 (Treatment group)Experimental Treatment1 Intervention

Surgical wound will be covered with the PICO dressing.

Group II: Group 1 (Control group)Active Control1 Intervention

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

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Walter C HembreeLead Sponsor

Smith & Nephew, Inc.Industry Sponsor

165 Previous Clinical Trials

22,331 Total Patients Enrolled

Walter C Hembree, MDPrincipal InvestigatorMedStar Health

Media Library

PICO dressing (Negative Pressure Wound Therapy System) Clinical Trial Eligibility Overview. Trial Name: NCT05064696 — N/A

PICO dressing (Negative Pressure Wound Therapy System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064696 — N/A

Total Ankle Replacement Research Study Groups: Group 1 (Control group), Group 2 (Treatment group)

Total Ankle Replacement Clinical Trial 2023: PICO dressing Highlights & Side Effects. Trial Name: NCT05064696 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum participant capacity for this experiment?

"Affirmative, the information available on clinicaltrials.gov implies that this trial is still in need of research subjects. Initially presented to the public on August 25th 2021 and most recently updated June 1st 2022, it requires 150 individuals to be enrolled from two distinct medical centres."

Answered by AI

Is this experiment currently in the process of enrolling participants?

"Clinicaltrials.gov reveals that this medical trial, which was initially posted on August 25th 2021, is currently in need of patients. The most recent update to the listing occurred June 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PICO- Single-use Negative Pressure Wound Therapy System

Walter C Hembree 2021. "PICO- Single-use Negative Pressure Wound Therapy System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05064696.