RecruitingNot ApplicableNCT04076397

Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae

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


Sponsor

University Hospital, Brest

Enrollment

40 participants

Start Date

Jul 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for people who have persistent numbness, tingling, or pain (dysesthesia) in a fingertip after it was injured and healed. One treatment is lipofilling, a procedure where fat is taken from elsewhere in your body and injected into the damaged fingertip to repair the tissue. The other approach is conservative treatment — meaning physical therapy, pain management, or other non-surgical options. The study looks at which approach better relieves the abnormal sensations that can make daily activities difficult after fingertip trauma. Fingerip injuries are common and the resulting chronic pain and numbness can be surprisingly debilitating, affecting work and quality of life. Lipofilling has shown promise in reconstructive surgery, but has not been directly compared to non-surgical care for this specific problem. This trial aims to provide clear evidence to guide treatment recommendations. You may be eligible if: - You are between 18 and 75 years old - You have had a fingertip injury on one finger only, below the distal joint - Your finger was treated with directed healing or a skin flap - You have troublesome fingertip dysesthesia (pain/numbness) lasting 6 to 24 months - Your neuropathic pain scores 4 or higher out of 10 on the DN4 scale You may NOT be eligible if: - You have a skin infection, or the injury was above the distal joint, or it involved reimplantation - Your dysesthesia has been present for more than 24 months - You have multi-finger trauma - You are pregnant or breastfeeding - You have a tumour history on the affected finger - You have allergies to local anaesthetics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREautologous 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

OTHERdesensitization

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


Locations(2)

CHRU de Brest

Brest, France

CH de Cornouaille - Quimper

Quimper, France

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NCT04076397