UnknownNot Applicable

PICO- Single-use Negative Pressure Wound Therapy System

United States150 participantsStarted 2021-08-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wound complications

Timeframe: Approximately 12-weeks after surgery (or until 3-month postop visit is completed)

Trial details

NCT IDNCT05064696

SponsorWalter C Hembree

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Contact for this trial

Amy Loveland

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

View on ClinicalTrials.gov More Total Ankle Arthroplasty trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.