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

Primary Purpose

Skin Cancer, Basal Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MMS + Autologous patch
MMS and secondary intention healing
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Cancer focused on measuring Skin Cancer, Basal Cell Carcinoma, Mohs micrographic surgery, MMS, Autologous patch, Secondary intention healing

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MMS + Autologous patch

MMS + Secondary intention healing

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Difference in microbiology between intervention wounds and control wounds.
Swab test for microbiome analysis will be conducted at day 1 and day 11-13.

Full Information

First Posted
December 10, 2021
Last Updated
March 15, 2023
Sponsor
Bispebjerg Hospital
Collaborators
Benzon Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05170035
Brief Title
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery
Official Title
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Benzon Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Basal Cell Carcinoma
Keywords
Skin Cancer, Basal Cell Carcinoma, Mohs micrographic surgery, MMS, Autologous patch, Secondary intention healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
Blinded photo assesment of wound healing by two independent trained clinical doctors.
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MMS + Autologous patch
Arm Type
Experimental
Arm 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.
Arm Title
MMS + Secondary intention healing
Arm Type
Active Comparator
Arm Description
Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing
Intervention Type
Procedure
Intervention Name(s)
MMS + Autologous patch
Intervention Description
A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.
Intervention Type
Procedure
Intervention Name(s)
MMS and secondary intention healing
Intervention Description
Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)
Primary Outcome Measure Information:
Title
Blinded assesment of wound healing at day 18-20.
Description
Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.
Time Frame
Day 18-20
Secondary Outcome Measure Information:
Title
Blinded assesment of wound healing at day 11-13
Description
Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no.
Time Frame
day 11-13
Title
TEWL measurement
Description
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.
Time Frame
day 11-13 and day 18-20
Title
Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.
Description
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.
Time Frame
6 months
Title
Difference in microbiology between intervention wounds and control wounds.
Description
Swab test for microbiome analysis will be conducted at day 1 and day 11-13.
Time Frame
day 1 and day 11-13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Presenting relevant medical record report at study initiation Written informed consent obtained from subject Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation. Exclusion Criteria: A subjects with major systemic disease not yet stabilized Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. Pregnant or breast feeding Unable to follow the outlined study protocol Participation in other studies at the same time that may affect the wound healing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine E Karmisholt, MD, PhD
Phone
+4561664351
Email
katrine.elisabeth.karmisholt@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anna A Harager, Bsc
Phone
+4531333953
Email
Anna.ahm.harager@regionh.dk
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrine E Karmisholt, Ph.D.
Email
Katrine.elisabeth.karmisholt@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anna A Harager
Phone
+4531333953
Email
Anna.ahm.harager@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

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

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