Comparing wound dressings after ankle surgery
Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing
This study tests whether a special PICO dressing works better than regular gauze in helping patients heal after ankle surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05064696 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of the PICO dressing against standard non-stick gauze dressing in preventing wound complications in patients undergoing total ankle arthroplasty. Participants will be randomly assigned to receive either the PICO dressing or the standard dressing after their surgery. The study will assess wound complications through evaluations, patient-reported outcomes, and peri- and post-operative data. The goal is to determine which dressing leads to better healing outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for total ankle arthroplasty or uncomplicated revision total ankle arthroplasty.
Not a fit: Patients with a history of deep infections or wound complications requiring surgical intervention, as well as those with allergies to study products, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced complications for patients undergoing ankle surgery.
How similar studies have performed: Other studies have shown promising results with negative pressure wound therapy, suggesting potential benefits in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Amy Loveland — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Walter C Hembree, MD — MedStar Health
- Study coordinator: Amy Loveland
- Email: amy.loveland@medstar.net
- Phone: 301-560-2937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.