NCT04623372

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 3, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

November 9, 2020

Last Update Submit

March 8, 2022

Conditions

Punch Skin Biopsy

Keywords

skin biopsysuturewound healing

Outcome Measures

Primary Outcomes (1)

  • Assess aesthetic quality of the scar by physician

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

    one month after skin punch biopsy

Secondary Outcomes (5)

  • Assess aesthetic quality of the scar by patient

    1 month after skin biopsy punch

  • Assess maximal pain experienced by the patient

    1 month after skin biopsy punch

  • Assess amount of bleeding

    immediately after skin biopsy punch

  • Assess clotting time

    immediately after skin biopsy punch

  • Observe cutaneous infection

    1 month after skin biopsy punch

Study Arms (2)

suture

EXPERIMENTAL
Procedure: suture

Directed wound healing

EXPERIMENTAL
Procedure: directed wound healing

Interventions

suturePROCEDURE

suture by separated knots using a non-absorbable 4.0 wire and application of a dry dressing after the punch skin-biopsy

suture
directed wound healingPROCEDURE

application of a dry dressing without any prior suture after the skin biopsy.

Directed wound healing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Central Study Contacts

Christelle JADEAU

CONTACT

02 44 71 07 81cjadeau@ch-lemans.fr

Arthur VRIGNAUD, MD

CONTACT

02 43 43 43 43avrignaud@ch-lemans.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: two parallel groups, in a non-inferiority setting, without any pairing or stratification
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 10, 2020

Study Start

February 3, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

FR(1)