Evaluating a new dressing system for skin grafts after fibula free flap surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mentalization-based therapy for children and adolescents referred for aggressive or violent behaviour

  This trial will test whether mentalization-based therapy helps young people aged 10–17 referred to specialist services for aggressive or violent behaviour reduce those behaviours and improve how they understand themselves and others.

  Recruiting at 5 sites Anna Freud · Southampton, Calmore and 7 other locations · NCT07091721

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.