NCT04628416 Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.
| NCT ID | NCT04628416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Carcinomatous Resections |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2021-01-18 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2021-01-18 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. A prospective randomized evaluation will be done, comparing the PICO® to a conventional dressing. The main aim of the study is the evaluation of the impact of this portative system on the healing of the skin grafted donor site, in terms of rate of skin take, time of healing, complications and medical costs. The patients will be seen preoperatively to decide on their inclusion in the protocol. They will be reviewed at day 10 to evaluate the engraftment and possible local complications on the donor site. They will then be reviewed at day 20 and day 30 and until complete healing. The follow up will be of 12 months maximum. A medical cost evaluation will be done comparing the costs generated by the care on the donor site in the 2 groups.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04628416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinomatous Resections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04628416 currently recruiting?
Yes, NCT04628416 is actively recruiting participants. Contact the research team at m-deboutray@chu-montpellier.fr for enrollment information.
Where is the NCT04628416 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT04628416 clinical trial?
NCT04628416 is sponsored by University Hospital, Montpellier. The trial plans to enroll 112 participants.