Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

Skin Cancer Clinical Trial

Official title:

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170035
• Other study ID #: Autologous Patch-project
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 2024

Study information

• Verified date: March 2023
• Source: Bispebjerg Hospital
• Contact: Katrine E Karmisholt, MD, PhD
• Phone: +4561664351
• Email: katrine.elisabeth.karmisholt[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell
• Skin Cancer
• Skin Neoplasms

Intervention

Procedure:
• MMS + Autologous patch
A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.
• MMS and secondary intention healing
Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Benzon Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	day 11-13 and day 18-20
Secondary	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
Secondary	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