Skin CancerNCT05170035
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery
A study testing MMS + Autologous patch and MMS and secondary intention healing in people with Skin Cancer and Basal Cell Carcinoma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Skin Cancer, Basal Cell Carcinoma
- What is being tested?
- MMS + Autologous patch and MMS and secondary intention healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen
Katrine E Karmisholt, Ph.D., Katrine.elisabeth.karmisholt@regionh.dk
Anna A Harager, +4531333953, Anna.ahm.harager@regionh.dk
About this study
Official title: 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.
- Conditions
- Skin Cancer, Basal Cell Carcinoma
- Being tested
- MMS + Autologous patch, MMS and secondary intention healing
- Keywords
- Skin Cancer, Basal Cell Carcinoma, Mohs micrographic surgery, MMS, Autologous patch, Secondary intention healing
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMS + Autologous patchProcedure or surgery
A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.
MMS and secondary intention healingProcedure or surgery
Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: MMS + Autologous patch |
| MMS + Secondary intention healing | Active comparator | Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing Receives: Procedure: MMS and secondary intention healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 18-20
Secondary outcomes (4)
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.
Measured: day 11-13
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.
Measured: day 11-13 and day 18-20
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.
Measured: 6 months
Difference in microbiology between intervention wounds and control wounds.
Swab test for microbiome analysis will be conducted at day 1 and day 11-13.
Measured: day 1 and day 11-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Feb 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Benzon Foundation
- Responsible party
- Principal investigator, Katrine Elisabeth Karmisholt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170035
- Sponsor's protocol ID
- Autologous Patch-project
- Status last verified
- Mar 2023
- First submitted
- 10 Dec 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05170035
- Acronym / sponsor ID
- Autologous Patch-project
- Conditions
- Skin Cancer, Basal Cell Carcinoma
- Keywords
- Skin Cancer, Basal Cell Carcinoma, Mohs micrographic surgery, MMS, Autologous patch, Secondary intention healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Benzon Foundation
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| MMS + Autologous patch | Experimental | Procedure: MMS + Autologous patchMohs 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. |
| MMS + Secondary intention healing | Active comparator | Procedure: MMS and secondary intention healingMohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMS + Autologous patchA patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample. | Procedure or surgery | MMS + Autologous patch |
| MMS and secondary intention healingMohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing) | Procedure or surgery | MMS + Secondary intention healing |
Primary outcome
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.
4 secondary outcomes
Blinded assesment of wound healing at day 11-13
Time frame: day 11-13
TEWL measurement
Time frame: 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
Difference in microbiology between intervention wounds and control wounds.
Time frame: day 1 and day 11-13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMS + Autologous patch and MMS and secondary intention healing in people with Skin Cancer and Basal Cell Carcinoma, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrine E Karmisholt, MD, PhD (+4561664351, katrine.elisabeth.karmisholt@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinded assesment of wound healing at day 18-20. (time frame: Day 18-20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.