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AzTrials

Skin CancerNCT06014619

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

An observational study of Skin Cancer and Complication, run by Maastricht University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Mohs surgery and Slow Mohs surgery
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteNetherlands
Study dates
1 Aug 2023to Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients treated with

Who may be able to join

  • patients with a cutaneous lesion with an indication for Mohs micrographic surgery or Slow Mohs
  • patients who received a treatment with either Mohs or Slow Mohs between 1 july 2017 and 1 july 2023 at the dermatology department of the Maastricht University Medical Center+.

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center+

    Maastricht

Other trials in Netherlands

About this study

Official title: Clinical Presentation and Surgical Outcomes in Patients With Skin Disorders Treated With Mohs Micrographic Surgery and Slow Mohs.

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

Being tested
Mohs surgery, Slow Mohs surgery
Keywords
Clinical presentation, Outcomes, Mohs micrographic surgery, Slow Mohs, Micrographic surgery
Medical subject headings
Skin Neoplasms, Postoperative Complications, Recurrence, Carcinoma, Basal Cell, Hutchinson's Melanotic Freckle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mohs surgeryProcedure or surgery

    Also called Mohs micrographic surgery, MMS, Mohs

    Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).

  • Slow Mohs surgeryProcedure or surgery

    Also called Slow Mohs

    Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).

Study groups in NCT06014619
Study groupRoleWhat they receive
Mohs Micrographic SurgeryPatients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands
Receives: Procedure: Mohs surgery
Slow MohsPatients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands
Receives: Procedure: Slow Mohs surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of complications

    The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.

    Measured: Within 1 month after completion of the surgical intervention.

  2. Incidence of recurrence

    The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages. Recurrence is defined as disease relapse after completion of treatment.

    Measured: Up to 5 year after completion of the surgical intervention.

Secondary outcomes (2)

  1. Hazard ratio of predisposing factors for complications

    Predisposing factors (patient- and tumor characteristics) for complications after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize the presence of diabetes, tobacco use and medication use to be predisposing factors for complications.

    Measured: Within 1 month after completion of the surgical intervention.

  2. Hazard ratio of predisposing factors for recurrence

    Predisposing factors (patient- and tumor characteristics) for recurrences after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize incomplete treatment, worse prognostic tumor factors (Stage III of IV, presence of perineural invasion or lymphovascular invasion) to be predisposing factors for recurrence.

    Measured: Up to 5 year after completion of the surgical intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start1 Aug 2023
  3. Primary completion1 Feb 2024
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014619
Sponsor's protocol ID
2023-0043
Status last verified
Mar 2025
First submitted
15 Aug 2023
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Lee CB, Roorda BM, Wakkee M, Voorham Q, Mooyaart AL, de Vijlder HC, Nijsten T, van den Bos RR. Recurrence rates of cutaneous squamous cell carcinoma of the head and neck after Mohs micrographic surgery vs. standard excision: a retrospective cohort study. Br J Dermatol. 2019 Aug;181(2):338-343. doi: 10.1111/bjd.17188. Epub 2018 Oct 28.

    PubMed 30199574

  • Lacerda PN, Lange EP, Luna NM, Miot HA, Nogueira VSN, Abbade LPF. Recurrence rate of basal cell carcinoma among different micrographic surgery techniques: systematic review with meta-analysis. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1178-1190. doi: 10.1111/jdv.18048. Epub 2022 Apr 1.

    PubMed 35274381

  • Cook JL, Perone JB. A prospective evaluation of the incidence of complications associated with Mohs micrographic surgery. Arch Dermatol. 2003 Feb;139(2):143-52. doi: 10.1001/archderm.139.2.143.

    PubMed 12588220

  • Nemer KM, Ko JJ, Hurst EA. Complications After Mohs Micrographic Surgery in Patients Aged 85 and Older. Dermatol Surg. 2021 Feb 1;47(2):189-193. doi: 10.1097/DSS.0000000000002452.

    PubMed 32796326

  • Merritt BG, Lee NY, Brodland DG, Zitelli JA, Cook J. The safety of Mohs surgery: a prospective multicenter cohort study. J Am Acad Dermatol. 2012 Dec;67(6):1302-9. doi: 10.1016/j.jaad.2012.05.041. Epub 2012 Aug 11.

    PubMed 22892283

  • Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.

    PubMed 24080866

  • Basu P, Goldenberg A, Cowan N, Eilers R, Hau J, Jiang SIB. A 4-year retrospective assessment of postoperative complications in immunosuppressed patients following Mohs micrographic surgery. J Am Acad Dermatol. 2019 Jun;80(6):1594-1601. doi: 10.1016/j.jaad.2018.11.032. Epub 2018 Nov 28.

    PubMed 30502411

  • Patel SA, Liu JJ, Murakami CS, Berg D, Akkina SR, Bhrany AD. Complication Rates in Delayed Reconstruction of the Head and Neck After Mohs Micrographic Surgery. JAMA Facial Plast Surg. 2016 Sep 1;18(5):340-6. doi: 10.1001/jamafacial.2016.0363.

    PubMed 27227423

  • Huether MJ, Griego RD, Brodland DG, Zitelli JA. Clindamycin for intraincisional antibiotic prophylaxis in dermatologic surgery. Arch Dermatol. 2002 Sep;138(9):1145-8. doi: 10.1001/archderm.138.9.1145.

    PubMed 12224974

  • Rogers HD, Desciak EB, Marcus RP, Wang S, MacKay-Wiggan J, Eliezri YD. Prospective study of wound infections in Mohs micrographic surgery using clean surgical technique in the absence of prophylactic antibiotics. J Am Acad Dermatol. 2010 Nov;63(5):842-51. doi: 10.1016/j.jaad.2010.07.029. Epub 2010 Aug 30.

    PubMed 20800320

  • Maragh SL, Brown MD. Prospective evaluation of surgical site infection rate among patients with Mohs micrographic surgery without the use of prophylactic antibiotics. J Am Acad Dermatol. 2008 Aug;59(2):275-8. doi: 10.1016/j.jaad.2008.03.042.

    PubMed 18638628

  • Xia Y, Cho S, Greenway HT, Zelac DE, Kelley B. Infection rates of wound repairs during Mohs micrographic surgery using sterile versus nonsterile gloves: a prospective randomized pilot study. Dermatol Surg. 2011 May;37(5):651-6. doi: 10.1111/j.1524-4725.2011.01949.x. Epub 2011 Apr 1.

    PubMed 21457390

Questions about this trial

What is this clinical trial studying?

An observational study of Skin Cancer and Complication, run by Maastricht University Medical Center at 1 site in Netherlands.

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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. 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 Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of complications (time frame: Within 1 month after completion of the surgical intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06014619, which also lists 12 linked publications.

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 4 Apr 2025.

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