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

Bispebjerg Hospital

Status: Enrolling

Conditions: Skin Cancer; Basal Cell Carcinoma

Treatments: Procedure: MMS + Autologous patch; Procedure: MMS and secondary intention healing

Study type: Interventional

Funder types: Other

Identifiers

NCT05170035

Autologous Patch-project

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

MMS + Autologous patch

Experimental group

Description:

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.

Treatment:

Procedure: MMS + Autologous patch

MMS + Secondary intention healing

Active Comparator group

Description:

Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing

Treatment:

Procedure: MMS and secondary intention healing