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

NCT ID: NCT05170035

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Cancer Basal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinded photo assesment of wound healing by two independent trained clinical doctors.

Study Groups

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MMS + Autologous patch

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.

Group Type EXPERIMENTAL

MMS + Autologous patch

Intervention Type PROCEDURE

A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.

MMS + Secondary intention healing

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

Group Type ACTIVE_COMPARATOR

MMS and secondary intention healing

Intervention Type PROCEDURE

Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

Interventions

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MMS + Autologous patch

A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.

Intervention Type PROCEDURE

MMS and secondary intention healing

Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benzon Foundation

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Katrine Elisabeth Karmisholt

MD, Chief Consultant, Ass.Prof., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Katrine E Karmisholt, MD, PhD

Role: CONTACT

+4561664351

Anna A Harager, Bsc

Role: CONTACT

+4531333953

Facility Contacts

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Katrine E Karmisholt, Ph.D.

Role: primary

Anna A Harager

Role: backup

+4531333953

Other Identifiers

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Autologous Patch-project

Identifier Type: -

Identifier Source: org_study_id

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