Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae

NCT ID: NCT04076397

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-02

Study Completion Date

2028-04-02

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.

Detailed Description

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Conditions

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Distal Amputation of the Fingers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

autologous transplant reinjection

Intervention Type 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

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

Group Type OTHER

desensitization

Intervention Type OTHER

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

Interventions

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autologous transplant reinjection

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

Intervention Type PROCEDURE

desensitization

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

CH de Cornouaille - Quimper

Quimper, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne PERRUISSEAU-CARRIER, Dr

Role: CONTACT

02.08.34.25.11

Facility Contacts

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Anne PERRUISSEAU-CARRIER, Dr

Role: primary

02.08.34.25.11

Anne-Charlotte MONNERIE, Dr

Role: primary

Other Identifiers

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29BRC19.0081

Identifier Type: -

Identifier Source: org_study_id

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