Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae (LIPOFILLING)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Distal Amputation of the Fingers

Treatments: Other: desensitization; Procedure: autologous transplant reinjection

Study type: Interventional

Funder types: Other

Identifiers

NCT04076397

29BRC19.0081

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

lipofilling group

Other group

Description:

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

Treatment:

Procedure: autologous transplant reinjection

desensitization group

Other group

Description:

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

Treatment:

Other: desensitization