Clinical trial NCT04623372: Immediate Suture or Directed Wound Healing? Comparative Study of Their Respective Values Following a Punch Skin Biopsy (CICAT)
Official title: Immediate Suture or Directed Wound Healing? Comparative Study of Their Respective Values Following a Punch Skin Biopsy (CICAT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Punch Skin Biopsy
Keywords: skin biopsy
suture
wound healing
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two parallel groups, in a non-inferiority setting, without any pairing or stratification
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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 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

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 over the past 30 days (condition of exclusivity)

Primary outcomes:
measure: Assess aesthetic quality of the scar by physician
timeFrame: one month after skin punch biopsy
Secondary outcomes:
measure: Assess aesthetic quality of the scar by patient
timeFrame: 1 month after skin biopsy punch
measure: Assess maximal pain experienced by the patient
timeFrame: 1 month after skin biopsy punch
measure: Assess amount of bleeding
timeFrame: immediately after skin biopsy punch
measure: Assess clotting time
timeFrame: immediately after skin biopsy punch
measure: Observe cutaneous infection
timeFrame: 1 month after skin biopsy punch
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References: