Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae

NCT04076397 | Recruiting

• 1 other identifier: 29BRC19.0081
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Distal Amputation of the Fingers

Keywords

annoying pulpal dysesthesia; lipofilling; amputation; sequelae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective self-assessment of the overall functional ability of both upper limbs

  Day 0, Day 15, Month1, Month3, Month6

Other Outcomes (2)

• Neuropathic pain

  Day 0, Day 15, Month 1, Month 3, Month 6

• Patient satisfaction on the esthetic aspect of the finger

  Month 6

Study Arms (2)

lipofilling group

OTHER

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

desensitization group

OTHER

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

Interventions

autologous transplant reinjection PROCEDURE

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

lipofilling group

desensitization OTHER

Patients will have to stimulate the pulp of your finger on a daily basis

desensitization group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU de Brest

Brest, 29200, France

RECRUITING

CH de Cornouaille - Quimper

Quimper, 29107, France

RECRUITING

MeSH Terms

Interventions

Desensitization, Psychologic

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Anne PERRUISSEAU-CARRIER, Dr

CONTACT

02.08.34.25.11; anne.perruisseaucarrier@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: July 2, 2020
• Primary Completion (Estimated): April 2, 2028
• Study Completion (Estimated): April 2, 2028
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (2)