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临床试验/NCT04623372
NCT04623372已完成不适用

Immediate Suture or Directed Wound Healing? Comparative Study of Their Respective Values Following a Punch Skin Biopsy (CICAT)

Centre Hospitalier le Mans2 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2021年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
290
试验地点
2
主要终点
Assess aesthetic quality of the scar by physician

研究概览

简要总结

The skin punch-biopsies are frequently used technical acts in the current medical practice. However, while these skills are actually easy to perform, the subsequent healing procedure remains still poorly harmonized. Indeed, it usually depends on the physicians personal experiences and some preconceived considerations without any reliable scientific background. This study aims to explore the performances of a directed wound healing behaviour in comparison with the suture.

详细描述

Because of the lack of reliable scientific data about this topic, the usual behaviours concerning the subsequent healing procedure after a punch skin biopsy remains still poorly defined and harmonized, currently based on the physicians personal experiences and some preconceived considerations. The few studies available in the literature are supporting the assumption that the use of a directed wound healing could be as effective as the widely-used procedure of performing a suture while it does not downgrade the quality of care. However, due to their methodological quality and applicability, they have not led to a substantial modification of the common behaviours. Moreover, the development of some new and the improvement of the former resources could have changed the situation. Therefore, this study aims to bring some recent pragmatic data to assist the implementation of recommendations regarding the attitude to adopt for the healing procedure after a skin punch-biopsy.

The protocol will consist in a monocentric, prospective, randomized and controlled, interventional study. It will be carried out with two parallel groups, in a non-inferiority setting. All the included participants will undergo a skin biopsy using a punch of 4 mm diameter. Then they will either get a suture by separated knots using a non-absorbable 4.0 wire and a dry dressing, either get only a dry dressing. All the subjects will receive a phone call at five days after the skin biopsy in order to collect the self-evaluation of the maximal experienced pain during the healing period. They will also have a single follow-up appointment one month after the inclusion and a photograph of the scar will be taken during this medical consultation. This picture will be evaluated by a blind independent investigator without the presence of the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

One month after the inclusion a photograph of the scar will be taken. This picture will be evaluated by a blind independent investigator without the presence of the patient.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult person (age greater than or equal to 18 years)
  • either hospitalized patient in a conventional or in a day care department, either seen at a medical appointment in Le Mans General Hospital
  • person on whom the indication of one or several skin biopsy(ies) using a punch of 4 mm diameter has been established
  • affiliated or beneficiary of a statutory social insurance scheme
  • free and informed written consent, signed by both the participant and the investigator (the day of inclusion at the latest and prior to any examination needed by the protocol) after an oral and written information

排除标准

  • skin biopsy on the face or the cervical area
  • pregnant, breastfeeding or parturient woman
  • person deprived of liberty by an administrative act or a court decision
  • patient requiring compulsory mental health care
  • minor or legally protected adult
  • patient that is no longer in a condition to express his or her wishes
  • person that have participated or that are taking part in an interventional study over the past 30 days (condition of exclusivity)

研究组 & 干预措施

suture

Experimental

干预措施: suture (Procedure)

Directed wound healing

Experimental

干预措施: directed wound healing (Procedure)

结局指标

主要结局

Assess aesthetic quality of the scar by physician

时间窗: one month after skin punch biopsy

the asserted aesthetic quality of the scar will be assessed by a dermatologist with 4-level scale

次要结局

  • Assess maximal pain experienced by the patient(1 month after skin biopsy punch)
  • Assess aesthetic quality of the scar by patient(1 month after skin biopsy punch)
  • Assess clotting time(immediately after skin biopsy punch)
  • Observe cutaneous infection(1 month after skin biopsy punch)
  • Assess amount of bleeding(immediately after skin biopsy punch)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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