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New treatment option for Carcinomatous Resections
Official title Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.
ClinicalTrials.gov ID: NCT04628416
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Signature of informed consent.
You likely can't join 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
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.