Evaluating a new dressing system for skin grafts after fibula free flap surgery
Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.
This study is testing if a new type of dressing can help skin grafts heal better after surgery for people getting a fibula free flap.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04628416 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the PICO® negative pressure dressing system on the healing of skin grafts at the donor site of fibula free flaps. The study will compare the outcomes of patients using the PICO® dressing to those using a conventional dressing method. It involves a prospective randomized evaluation, where patients requiring a fibula free flap for reconstruction will be enrolled and monitored postoperatively. The goal is to determine if the PICO® dressing can reduce the rate of graft loss due to local devascularization.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require a fibula free flap with a skin paddle and need a skin graft for donor site closure.
Not a fit: Patients with contraindications for a fibula free flap or negative pressure therapy, as well as those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes for patients undergoing fibula free flap surgeries.
How similar studies have performed: Other studies have shown promising results with negative pressure dressings in various surgical contexts, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * Any patient requiring a fibula free flap with skin paddle * Theoretical need of a skin graft for the closure of the donor site (evaluated by the surgeon in charge of the patient at the time of inclusion) and performed at the same time as the fibula flap * Signature of informed consent. Exclusion Criteria: * Contraindication to making a fibula free flap: * anesthetic contraindication, * atheroma in the leg arteries obstructing more than 60% of the arterial lumen (objectified by CT angiography of lower limbs) * Contraindication to the setting up of a negative pressure therapy: * allergy to one of the PICO® components * infection in the donor area * cutaneous lesions of the lower limb preventing the placement of an occlusive dressing or making it impossible to seal the device * No affiliation to a social security scheme. * Minor or major patients who are protected or unable to give their consent (according to article L1121-8 of the Public Health Code (PHC)) * Pregnant or lactating women (according to article L1121-5 of the PHC) * Vulnerable people (according to article L1121-6 of the PHC)
Where this trial is running
Montpellier
- Marie DE BOUTRAY — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Marie De Boutray, MD
- Email: m-deboutray@chu-montpellier.fr
- Phone: 04 67 33 97 32
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.