- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04076397
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Anne PERRUISSEAU-CARRIER, Dr
- Phone Number: 02.08.34.25.11
- Email: anne.perruisseaucarrier@chu-brest.fr
Study Locations
-
-
-
Brest, France, 29200
- Recruiting
- CHRU de Brest
-
Contact:
- Anne PERRUISSEAU-CARRIER, Dr
- Phone Number: 02.08.34.25.11
- Email: anne.perruisseaucarrier@chu-brest.fr
-
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
- Recruiting
- CH de Cornouaille - Quimper
-
Contact:
- Anne-Charlotte MONNERIE, Dr
- Email: anne-charlotte.monnerie@chu-brest.fr
-
Principal Investigator:
- Anne-Charlotte MONNERIE, Dr
-
-
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:
Patients in the lipofilling group will also have:
|
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:
|
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.
Sponsor
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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