Status:
RECRUITING
Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae
Lead Sponsor:
University Hospital, Brest
Conditions:
Distal Amputation of the Fingers
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 2 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04076397
Start Date
July 2 2020
End Date
April 2 2028
Last Update
July 13 2022
Active Locations (2)
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1
CHRU de Brest
Brest, France, 29200
2
CH de Cornouaille - Quimper
Quimper, France, 29107