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

NCT ID: NCT04628416

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinomatous Resections Violent Trauma

Keywords

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fibula free flap skin graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental arm

Group Type EXPERIMENTAL

PICO dressing

Intervention Type DEVICE

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

Control

Group Type OTHER

Conventional dressing

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Conventional dressing

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marie DE BOUTRAY

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie De Boutray, MD

Role: CONTACT

Phone: 04 67 33 97 32

Email: [email protected]

Facility Contacts

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Marie DE BOUTAY

Role: primary

Other Identifiers

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2020-A00425-34

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL20_0047

Identifier Type: -

Identifier Source: org_study_id