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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04076397
Acronym
LIPOFILLING
Enrollment
40
Registered
2019-09-03
Start date
2020-07-02
Completion date
2028-04-02
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Amputation of the Fingers

Keywords

annoying pulpal dysesthesia, lipofilling, amputation, sequelae

Brief summary

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

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

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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease of the EVA between D0 and M6Day 0, Month 6visual analogue scale from 0 to 10, knowing that 0 is the absence of discomfort and intolerable discomfort

Secondary

MeasureTime frameDescription
Subjective self-assessment of the overall functional ability of both upper limbsDay 0, Day 15, Month1, Month3, Month6DASH questionnaire (Disability of Arm-Shoulder-Hand)

Other

MeasureTime frameDescription
Neuropathic painDay 0, Day 15, Month 1, Month 3, Month 6DN4 score (questionnaire) : a score greater than or equal to 4 makes the diagnosis of neuropathic pain.
Patient satisfaction on the esthetic aspect of the fingerMonth 6Subjective satisfaction to the patient's appreciation.

Countries

France

Contacts

Primary ContactAnne PERRUISSEAU-CARRIER, Dr
anne.perruisseaucarrier@chu-brest.fr02.08.34.25.11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026