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

University Hospital Center (CHU)

Status

Enrolling

Conditions

Violent Trauma

Carcinomatous Resections

Treatments

Device: Conventional dressing

Device: PICO dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT04628416

RECHMPL20_0047

2020-A00425-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)