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

NCT04628416 | Recruiting

• 2 other identifiers: RECHMPL20_00472020-A00425-34
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinomatous Resections; Violent Trauma

Keywords

fibula free flap; skin graft

Outcome Measures

Primary Outcomes (1)

• The percentage of failure of skin grafting (surface on which the skin graft did not take)

  on Day 10 postoperative (+/- 2 days)

Secondary Outcomes (9)

• Delay between the day of the operation and the complete healing of the donor site of the fibula flap (in days)

  Through complete healing, a maximum of 1 year

• Rate of other surgery due to a problem on the skin grafted area.

  Through complete healing, a maximum of 1 year

• Tendon exposure rate evaluated at day 10 (+/- 2 days) and day 20 (+/- 2 days) by the surgeon during hospitalization or in consultation if the patient is discharged.

  Day 10 (+/- 2 days) and day 20 (+/- 2 days)

• Rate of infection of the grafted site at day 10 (+/- 2 days) and day 20 (+/- 2 days), evaluated by the surgeon during hospitalization or in consultation if the patient is discharged

  Day 10 (+/- 2 days) and day 20 (+/- 2 days)

• Evolution of the quality of life at 1 month postoperative (+/- 4 days) compared to preoperative (assessed by the Short Form-12 Health Survey Version 2 (SF-12v2))

  At 1 month after surgery

Study Arms (2)

Experimental arm

EXPERIMENTAL

Device: PICO dressing

Control

OTHER

Device: Conventional dressing

Interventions

PICO dressing DEVICE

Use of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites

Experimental arm

Conventional dressing DEVICE

use of a conventional dressing (parrafin gauze) on the split-thickness skin graft of fibula free flap donor sites

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• Any patient requiring a fibula free flap with skin paddle
• Signature of informed consent.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Marie DE BOUTRAY

Montpellier, France

RECRUITING

Central Study Contacts

Marie De Boutray, MD

CONTACT

04 67 33 97 32; m-deboutray@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled multicentered trial with blinded evaluation of the primary outcome, comparing 2 management techniques applied on the skin graft done on the donor sites of fibula free flaps.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 13, 2020
• Study Start: January 18, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

FR (1)