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

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04623372

CHM-2020/S11/02

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

adult person (age greater than or equal to 18 years)
either hospitalized patient in a conventional or in a day care department, either seenat 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 mmdiameter 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 theprotocol) after an oral and written information

Exclusion

Exclusion Criteria:

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 overthe past 30 days (condition of exclusivity)

Study Design

February 03, 2021

November 30, 2022

Study Description

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.

Connect with a study center

Centre Hospitalier Du Mans
Le Mans, 72000
France
Active - Recruiting

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