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

March 15, 2023 updated by: Katrine Elisabeth Karmisholt, Bispebjerg Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: MMS + Autologous patch
A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.
Active Comparator: MMS + Secondary intention healing
Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing
Procedure: MMS and secondary intention healing
Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blinded assesment of wound healing at day 18-20.
Time Frame: Day 18-20
Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.
Day 18-20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blinded assesment of wound healing at day 11-13
Time Frame: 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
Time Frame: 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.
day 11-13 and day 18-20
Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.
Time Frame: 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.
6 months
Difference in microbiology between intervention wounds and control wounds.
Time Frame: day 1 and day 11-13
Swab test for microbiome analysis will be conducted at day 1 and day 11-13.
day 1 and day 11-13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Benzon Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autologous Patch-project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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