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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suture | Experimental |
| |
| Directed wound healing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suture | Procedure | suture by separated knots using a non-absorbable 4.0 wire and application of a dry dressing after the punch skin-biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month after skin biopsy punch |
| Assess maximal pain experienced by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Du Mans | Le Mans | 72000 | France |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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two parallel groups, in a non-inferiority setting, without any pairing or stratification
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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.
| directed wound healing | Procedure | application of a dry dressing without any prior suture after the skin biopsy. |
|
The maximal pain experienced by the patient during the Healing phase will be assessed with a numerical scale ranging from 0 to 10
| 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 | immediately after skin biopsy punch |
| Assess clotting time | The clotting time subsequent to the skin biopsy will be assessed using a 4-level scale | 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 | 1 month after skin biopsy punch |