New skin flap could reduce surgery side effects for head and neck cancer patients
NCT ID NCT05757817
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new surgical technique using a thin skin flap from the groin area to rebuild the mouth or throat after cancer removal. The goal is to see if it causes fewer problems at the donor site compared to standard flaps. Forty adults with head and neck cancer will be followed for a year to check for complications like flap failure or infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- External pudendal artery flap (STEPA flap) surgical procedure
- What this could lead to
- If successful, this could offer a safer reconstructive option for head and neck cancer patients, with fewer complications at the donor site.
- What could go wrong
- This is an early-phase study with only 40 patients, so results may not apply broadly. Risks include flap failure or rare infection (Fournier gangrene).
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx. 2. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0/N2c M0 (no distant metastasis M0). 3. Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon. 4. Patient OMS 0-1. 5. Age ≥ 18. 6. Patient with no contraindication to surgery. 7. Patient affiliated to a Social Health Insurance in France. 8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol. Exclusion Criteria: 1. Patient with history of prior cervical surgery and/or radiation to the head and neck. 2. History of pelvic surgery and/or radiation to the pelvic area. 3. Patients with a contraindication to any form of sedation. 4. Patient with irreversible coagulopathy. 5. Patient with a contraindication to a CT scan or an injection of iodinated contrast medium. 6. Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose \> 10 mg of prednisone or equivalent) or other immunosuppressive therapy. 7. Pregnant or breastfeeding women. 8. Patient with another co-existing malignancy at the time of inclusion or any other significant medical, psychiatric, or surgical condition currently not controlled by treatment, which may interfere with the conduct of the study. 9. Patient with diabetes (type 1 or 2). 10. Patient with a BMI \> 30kg/m². 11. Any psychological, family, geographic or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for in the study protocol . 12. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Antoine Lacassagne
RECRUITINGNice, France
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Chu Gui de Chauliac
NOT_YET_RECRUITINGMontpellier, France
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Chu Purpan
NOT_YET_RECRUITINGToulouse, France
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Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
RECRUITINGToulouse, France
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Other studies related to the condition(s) this trial covers.
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- Can immunotherapy before surgery stop early oral cancer from returning?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Can a glowing dye show surgeons where head and neck tumors end?
- Re-irradiation plus cetuximab targets head and neck tumors that return