Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae
NCT ID: NCT04076397
Last Updated: 2022-07-13
Study Results
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-07-02
2028-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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lipofilling group
Patient will conduct a total of 4 visits: D15, M1, M3, M6 during which they will have: a clinical examination as well as the following evaluations:
* Make EVA (evaluation of the pain),
* Complete DASH questionnaire
* Complete DN4 questionnaire
Patients in the lipofilling group will also have:
* the repair of the last dressing during the consultation at J15
* Ablation of any threads
* Control of the digital and abdominal scar
* Making a photo of their finger at V1 and M6
autologous transplant reinjection
The patient is placed under loco-regional anesthesia. After sterilization of the upper limb and abdomen, the fat is removed at a fold by micro-incision by the Coleman method. The fat is decanted and micro-reinjected into the pulp of the patient's finger with 2 or 3 punctiform incisions. The quantity of fat injected is 2 to 3 mL. Incision of the abdomen and fingers is closed by points at monocryl 4/0. Finally, a fatty dressing is performed on the finger. Patients will benefit from nursing care every 2 days
desensitization group
Patient will conduct a total of 4 visits: D15, M1, M3, M6 during which they will have: a clinical examination as well as the following evaluations:
* Make EVA (evaluation of the pain),
* Complete DASH questionnaire
* Complete DN4 questionnaire
desensitization
Patients will have to stimulate the pulp of your finger on a daily basis
Interventions
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autologous transplant reinjection
The patient is placed under loco-regional anesthesia. After sterilization of the upper limb and abdomen, the fat is removed at a fold by micro-incision by the Coleman method. The fat is decanted and micro-reinjected into the pulp of the patient's finger with 2 or 3 punctiform incisions. The quantity of fat injected is 2 to 3 mL. Incision of the abdomen and fingers is closed by points at monocryl 4/0. Finally, a fatty dressing is performed on the finger. Patients will benefit from nursing care every 2 days
desensitization
Patients will have to stimulate the pulp of your finger on a daily basis
Eligibility Criteria
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Inclusion Criteria
* Patient with unidigital trauma downstream of distal interphalangeal joint
* Treated by directed healing OR covered by a flap
* Presenting troublesome pulpal dysesthesia evolving for more than 6 months AND less than 24 months
* The discomfort must be objectified by a DN4 score greater than or equal to 4/10 (neuropathic pain)
* Patient does not have any allergy to the substances used, in particular anesthetic: xylocaine, adrenaline
Exclusion Criteria
* Refusal of the patient to integrate the protocol Or incapacity to consent
* Pregnant or breastfeeding woman
* Tumor history of the amputated finger
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU de Brest
Brest, , France
CH de Cornouaille - Quimper
Quimper, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC19.0081
Identifier Type: -
Identifier Source: org_study_id
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