Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae (LIPOFILLING)

July 12, 2022 updated by: University Hospital, Brest

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

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

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Brest, France, 29200
        • Recruiting
        • CHRU de Brest
        • Contact:
        • Principal Investigator:
          • Anne PERRUISSEAU-CARRIER, Dr
        • Sub-Investigator:
          • Hoel LETISSIER, Dr
        • Sub-Investigator:
          • Anne-Charlotte MONNERIE, Dr
        • Sub-Investigator:
          • Alexandra TRIMAILLE, Dr
      • Quimper, France, 29107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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
Other: 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
Patients will have to stimulate the pulp of your finger on a daily basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of the EVA between D0 and M6
Time Frame: Day 0, Month 6
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
Time Frame: Day 0, Day 15, Month1, Month3, Month6
DASH questionnaire (Disability of Arm-Shoulder-Hand)
Day 0, Day 15, Month1, Month3, Month6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic pain
Time Frame: Day 0, Day 15, Month 1, Month 3, Month 6
DN4 score (questionnaire) : a score greater than or equal to 4 makes the diagnosis of neuropathic pain.
Day 0, Day 15, Month 1, Month 3, Month 6
Patient satisfaction on the esthetic aspect of the finger
Time Frame: Month 6
Subjective satisfaction to the patient's appreciation.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Anticipated)

April 2, 2028

Study Completion (Anticipated)

April 2, 2028

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 29BRC19.0081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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