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| Name | Class |
|---|---|
| Benzon Foundation | UNKNOWN |
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The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMS + Autologous patch | Experimental | Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch. |
|
| MMS + Secondary intention healing | Active Comparator | Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMS + Autologous patch | Procedure | A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded assesment of wound healing at day 18-20. | Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no. | Day 18-20 |
| Measure | Description | Time Frame |
|---|---|---|
| Blinded assesment of wound healing at day 11-13 | Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no. | day 11-13 |
| TEWL measurement | Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrine E Karmisholt, MD, PhD | Contact | +4561664351 | katrine.elisabeth.karmisholt@regionh.dk | |
| Anna A Harager, Bsc | Contact | +4531333953 | Anna.ahm.harager@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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A randomized controlled clinical trial
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Blinded photo assesment of wound healing by two independent trained clinical doctors.
| MMS and secondary intention healing | Procedure | Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing) |
|
| day 11-13 and day 18-20 |
| Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up. | The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points. | 6 months |
| Difference in microbiology between intervention wounds and control wounds. | Swab test for microbiome analysis will be conducted at day 1 and day 11-13. | day 1 and day 11-13 |
| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018295 | Neoplasms, Basal Cell |