Punch Skin BiopsyCICATNCT04623372
Immediate Suture or Directed Wound Healing? Comparative Study of Their Respective Values Following a Punch Skin Biopsy (CICAT)
A study testing suture and directed wound healing in people with Punch Skin Biopsy, run by Centre Hospitalier le Mans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Punch Skin Biopsy
- What is being tested?
- suture and directed wound healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2021to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Punch Skin Biopsy
- Being tested
- suture, directed wound healing
- Keywords
- skin biopsy, suture, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutureProcedure or surgery
suture by separated knots using a non-absorbable 4.0 wire and application of a dry dressing after the punch skin-biopsy
directed wound healingProcedure or surgery
application of a dry dressing without any prior suture after the skin biopsy.
| Study group | Role | What they receive |
|---|---|---|
| suture | Experimental | Not described Receives: Procedure: suture |
| Directed wound healing | Experimental | Not described Receives: Procedure: directed wound healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month after skin punch biopsy
Secondary outcomes (5)
Assess aesthetic quality of the scar by patient
The asserted aesthetic quality of the scar will be assessed by the participant himself using a 4-level scale
Measured: 1 month after skin biopsy punch
Assess maximal pain experienced by the patient
The maximal pain experienced by the patient during the Healing phase will be assessed with a numerical scale ranging from 0 to 10
Measured: 1 month after skin biopsy punch
Assess amount of bleeding
the scoring of the amount of bleeding subsequent to the skin biopsy will be assessed with a numerical scale ranging from 0 to 10
Measured: immediately after skin biopsy punch
Assess clotting time
The clotting time subsequent to the skin biopsy will be assessed using a 4-level scale
Measured: immediately after skin biopsy punch
Observe cutaneous infection
occurrence of a cutaneous infection that had required an antibiotic treatment and/or the achievement of a drainage during the month following the skin punch-biopsy
Measured: 1 month after skin biopsy punch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start3 Feb 2021
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Punch Skin BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two parallel groups, in a non-inferiority setting, without any pairing or stratification
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623372
- Sponsor's protocol ID
- CHM-2020/S11/02
- Acronym
- CICAT
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Suture or Directed Wound Healing? Comparative Study of Their Respective Values Following a Punch Skin Biopsy (CICAT)
- ClinicalTrials.gov ID
- NCT04623372
- Acronym / sponsor ID
- CICAT / CHM-2020/S11/02
- Conditions
- Punch Skin Biopsy
- Keywords
- skin biopsy, suture, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two parallel groups, in a non-inferiority setting, without any pairing or stratification
| Arm | Type | Receives |
|---|---|---|
| suture | Experimental | Procedure: suture |
| Directed wound healing | Experimental | Procedure: directed wound healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suturesuture by separated knots using a non-absorbable 4.0 wire and application of a dry dressing after the punch skin-biopsy | Procedure or surgery | suture |
| directed wound healingapplication of a dry dressing without any prior suture after the skin biopsy. | Procedure or surgery | Directed wound healing |
Primary outcome
Assess aesthetic quality of the scar by physician
Time frame: one month after skin punch biopsy
the asserted aesthetic quality of the scar will be assessed by a dermatologist with 4-level scale
5 secondary outcomes
Assess aesthetic quality of the scar by patient
Time frame: 1 month after skin biopsy punch
Assess maximal pain experienced by the patient
Time frame: 1 month after skin biopsy punch
Assess amount of bleeding
Time frame: immediately after skin biopsy punch
Assess clotting time
Time frame: immediately after skin biopsy punch
Observe cutaneous infection
Time frame: 1 month after skin biopsy punch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suture and directed wound healing in people with Punch Skin Biopsy, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess aesthetic quality of the scar by physician (time frame: one month after skin punch biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.