Carcinomatous ResectionsPICOFLAPNCT04628416
Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.
A study testing PICO dressing and Conventional dressing in people with Carcinomatous Resections and Violent Trauma, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinomatous Resections, Violent Trauma
- What is being tested?
- PICO dressing and Conventional dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Marie DE BOUTRAY
Montpellier
Marie DE BOUTAY
About this study
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
- Being tested
- PICO dressing, Conventional dressing
- Keywords
- fibula free flap, skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO dressingDevice
Use of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites
Conventional dressingDevice
use of a conventional dressing (parrafin gauze) on the split-thickness skin graft of fibula free flap donor sites
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Device: PICO dressing |
| Control | Other | Not described Receives: Device: Conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of failure of skin grafting (surface on which the skin graft did not take)
Measured: 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)
): complete epithelialization of the grafted site with disappearing crusts, this evaluation will be performed by the nurse at home with photos addressed to the doctor in charge of the patient. At the approach of complete healing the patient will be seen in consultation for the exact dating of the healing. If necessary, several close consultations will be conducted to evaluate the complete healing date within +/- 7 days
Measured: Through complete healing, a maximum of 1 year
Rate of other surgery due to a problem on the skin grafted area.
Measured: 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.
Measured: 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
Measured: 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))
Measured: At 1 month after surgery
Rate of patients for whom during of hospitalization was lengthened exclusively due to a problem with the skin graft. (Duration of hospitalization)
Measured: At 12 months
Evaluation of patient discomfort related to the PICO® device or to the standard dressing (noise, bulk, dressing) during the first 7 postoperative days. This discomfort is measured by an EVA of 0 to 100 measuring the discomfort experienced.
Measured: day 10
Treatment tolerance evaluation, measured wtih rate of adverse reaction
Measured: Day 20
Cost-effectiveness ratio. The medical and non-medical costs will be collect on the case report form
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start18 Jan 2021
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinomatous ResectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628416
- Sponsor's protocol ID
- RECHMPL20_0047
- Other IDs
- 2020-A00425-34
- Acronym
- PICOFLAP
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.
- ClinicalTrials.gov ID
- NCT04628416
- Acronym / sponsor ID
- PICOFLAP / RECHMPL20_0047
- Conditions
- Carcinomatous Resections, Violent Trauma
- Keywords
- fibula free flap, skin graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: PICO dressing |
| Control | Other | Device: Conventional dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Contraindication to making a fibula free flap:
- Contraindication to the setting up of a negative pressure therapy:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO dressingUse of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites | Device | Experimental arm |
| Conventional dressinguse of a conventional dressing (parrafin gauze) on the split-thickness skin graft of fibula free flap donor sites | Device | Control |
Primary outcome
The percentage of failure of skin grafting (surface on which the skin graft did not take)
Time frame: on Day 10 postoperative (+/- 2 days)
9 secondary outcomes
Delay between the day of the operation and the complete healing of the donor site of the fibula flap (in days)
Time frame: Through complete healing, a maximum of 1 year
Rate of other surgery due to a problem on the skin grafted area.
Time frame: 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.
Time frame: 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
Time frame: 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))
Time frame: At 1 month after surgery
Rate of patients for whom during of hospitalization was lengthened exclusively due to a problem with the skin graft. (Duration of hospitalization)
Time frame: At 12 months
Evaluation of patient discomfort related to the PICO® device or to the standard dressing (noise, bulk, dressing) during the first 7 postoperative days. This discomfort is measured by an EVA of 0 to 100 measuring the discomfort experienced.
Time frame: day 10
Treatment tolerance evaluation, measured wtih rate of adverse reaction
Time frame: Day 20
Cost-effectiveness ratio. The medical and non-medical costs will be collect on the case report form
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO dressing and Conventional dressing in people with Carcinomatous Resections and Violent Trauma, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie De Boutray, MD (04 67 33 97 32 ext. +33, m-deboutray@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of failure of skin grafting (surface on which the skin graft did not take) (time frame: on Day 10 postoperative (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.