Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.

Official Title
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Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study

Conditions
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Distal Amputation of the Fingers

Intervention / Treatment
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* Procedure: autologous transplant reinjection
* Other: desensitization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient (18 years old) and ≤ 75 years old 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: Patient with cutaneous sepsis, or amputation upstream of distal interphalangeal, or reimplantation, or dysesthesia that has been in progress for more than 24 months, or multi-digital traumatism Refusal of the patient to integrate the protocol Or incapacity to consent Pregnant or breastfeeding woman Tumor history of the amputated finger

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1: 1) with stratification on the center, the type of initial surgery (directed or flap scarring) and the duration of change of dysesthesia (≤ or> 1 year at baseline).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lipofilling group<br>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 | Procedure: autologous transplant reinjection<br>* 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<br>|
| Other: desensitization group<br>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 | Other: desensitization<br>* Patients will have to stimulate the pulp of your finger on a daily basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of the EVA between D0 and M6 | visual analogue scale from 0 to 10, knowing that 0 is the absence of discomfort and intolerable discomfort | Day 0, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective self-assessment of the overall functional ability of both upper limbs | DASH questionnaire (Disability of Arm-Shoulder-Hand) | Day 0, Day 15, Month1, Month3, Month6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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annoying pulpal dysesthesia, lipofilling, amputation, sequelae