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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Montpellier
NCT04628416 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A fibula free flap can be used for the reconstruction of a mandible or a maxillar when the lack of bonne exceeds 3cm. This flap is made of the fibula bone, some muscle around, the fibular vascular pedicle and a skin paddle to reconstruct the gum. Once this flap has been taken and transposed on the face, the leg is closed with a split thickness skin graft to replace the skin paddle. But the healing on this site is often a problem: this is partly due to the high rate of early graft's loss due to local devascularization (3 to 55% of loss). The skin grafting is generally improved by the application of a dressing sewn and left in place during 5 to 7 days postoperative (standard method). This study will evaluate the efficiency of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites, compared to the standard method

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📋 Eligibility rules (as published)
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)
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What it tests

  • PICO dressing
  • Conventional dressing
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Where

1 site
Marie DE BOUTRAY
Montpellier, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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