Basal Cell Carcinoma, Skin Cancer
Conditions
Keywords
Skin Cancer, Basal Cell Carcinoma, Mohs micrographic surgery, MMS, Autologous patch, Secondary intention healing
Brief summary
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.
Interventions
PROCEDUREMMS + Autologous patch
A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.
PROCEDUREMMS and secondary intention healing
Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)
Sponsors
Benzon Foundation
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded photo assesment of wound healing by two independent trained clinical doctors.
Intervention model description
A randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing 2. Presenting relevant medical record report at study initiation 3. Written informed consent obtained from subject 4. Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation.
Exclusion criteria
1. A subjects with major systemic disease not yet stabilized 2. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. 3. Pregnant or breast feeding 4. Unable to follow the outlined study protocol 5. Participation in other studies at the same time that may affect the wound healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinded assesment of wound healing at day 18-20. | Day 18-20 | Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blinded assesment of wound healing at day 11-13 | day 11-13 | Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no. |
| TEWL measurement | day 11-13 and day 18-20 | 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. |
| Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up. | 6 months | 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. |
| Difference in microbiology between intervention wounds and control wounds. | day 1 and day 11-13 | Swab test for microbiome analysis will be conducted at day 1 and day 11-13. |
Countries
Denmark
Contacts
Primary ContactKatrine E Karmisholt, MD, PhD
Backup ContactAnna A Harager, Bsc
Outcome results
None listed