NCT04628416

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinomatous Resections
• Violent Trauma

Interventions

Type	Name	Description
DEVICE	PICO dressing	Use of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites
DEVICE	Conventional dressing	use of a conventional dressing (parrafin gauze) on the split-thickness skin graft of fibula free flap donor sites

Timeline

• Start date: 2021-01-18
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2020-11-13
• Last updated: 2023-12-18

Locations

1 site across 1 country: France