Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae

Not Applicable

Recruiting

• Conditions: Distal Amputation of the Fingers
• Interventions: Procedure: autologous transplant reinjection; Other: desensitization

• Registration Number: NCT04076397
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2020-07-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13
• Primary Completion: 2028-04-02
• Study Completion: 2028-04-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lipofilling group	autologous transplant reinjection	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
desensitization group	desensitization	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

Primary Outcome Measures

Name	Time	Method
Decrease of the EVA between D0 and M6	Day 0, Month 6	visual analogue scale from 0 to 10, knowing that 0 is the absence of discomfort and intolerable discomfort

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHRU de Brest; 🇫🇷 Brest, France

CH de Cornouaille - Quimper; 🇫🇷 Quimper, France