Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Nov 12, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help heal the skin where tissue is taken from the leg (called the donor site) to reconstruct the jaw or face after surgery for cancer or injury. The study is comparing a special dressing called PICO®, which uses negative pressure to promote healing, to the standard dressing currently used. The goal is to see if the PICO® dressing helps the skin graft heal better, reduces complications, and is more cost-effective.

To participate in the trial, you need to be at least 18 years old and require a fibula free flap, which means your doctor has determined you need tissue from your leg to close a wound. You'll need to sign a consent form, and if you qualify, you'll be monitored at various points after your surgery to check how well the graft is healing. The study will follow participants for up to one year, looking at healing rates and any issues that may arise. It's a chance to contribute to medical research that could improve recovery for many patients in the future.

Gender

ALL

Eligibility 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)