NCT04076397撤回不适用
Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Decrease of the EVA between D0 and M6
研究概览
简要总结
The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
lipofilling group
Other
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
干预措施: autologous transplant reinjection (Procedure)
desensitization group
Other
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
干预措施: desensitization (Other)
结局指标
主要结局
Decrease of the EVA between D0 and M6
时间窗: Day 0, Month 6
visual analogue scale from 0 to 10, knowing that 0 is the absence of discomfort and intolerable discomfort
次要结局
- Subjective self-assessment of the overall functional ability of both upper limbs(Day 0, Day 15, Month1, Month3, Month6)
研究者
研究点 (4)
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