NCT05170035

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

December 10, 2021

Last Update Submit

March 15, 2023

Conditions

Skin CancerBasal Cell Carcinoma

Keywords

Skin CancerBasal Cell CarcinomaMohs micrographic surgeryMMSAutologous patchSecondary intention healing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Blinded assesment of wound healing at day 11-13

    day 11-13

  • TEWL measurement

    day 11-13 and day 18-20

  • Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.

    6 months

  • Difference in microbiology between intervention wounds and control wounds.

    day 1 and day 11-13

Study Arms (2)

MMS + Autologous patch

EXPERIMENTAL

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

MMS + Secondary intention healing

ACTIVE COMPARATOR

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

Procedure: MMS and secondary intention healing

Interventions

MMS + Autologous patchPROCEDURE

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

MMS + Autologous patch
MMS and secondary intention healingPROCEDURE

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

MMS + Secondary intention healing

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Skin NeoplasmsCarcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal Cell

Central Study Contacts

Katrine E Karmisholt, MD, PhD

CONTACT

+4561664351katrine.elisabeth.karmisholt@regionh.dk

Anna A Harager, Bsc

CONTACT

+4531333953Anna.ahm.harager@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded photo assesment of wound healing by two independent trained clinical doctors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Chief Consultant, Ass.Prof., PhD

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 27, 2021

Study Start

February 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

DK(1)