Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

NCT06014619 | Active Not Recruiting

• 1 other identifier: 2023-0043
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Cancer; Complication; Complication of Surgical Procedure; Complication,Postoperative; Recurrence; Recurrent Disease; Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma; Lentigo Maligna; Lentigo Maligna Melanoma

Keywords

Clinical presentation; Outcomes; Mohs micrographic surgery; Slow Mohs; Micrographic surgery

Outcome Measures

Primary Outcomes (2)

• Incidence of complications

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

  Within 1 month after completion of the surgical intervention.

• 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.

  Up to 5 year after completion of the surgical intervention.

Secondary Outcomes (2)

• Hazard ratio of predisposing factors for complications

  Within 1 month after completion of the surgical intervention.

• Hazard ratio of predisposing factors for recurrence

  Up to 5 year after completion of the surgical intervention.

Study Arms (2)

Mohs Micrographic Surgery

Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Procedure: Mohs surgery

Slow Mohs

Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Procedure: Slow Mohs surgery

Interventions

Mohs surgery PROCEDURE

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

Also known as: Mohs micrographic surgery, MMS, Mohs

Mohs Micrographic Surgery

Slow Mohs surgery PROCEDURE

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

Also known as: Slow Mohs

Slow Mohs

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with

You may qualify if:

• 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+.

You may not qualify if:

• None.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Related Publications (12)

• 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.

  PMID: 30199574 BACKGROUND

• 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.

  PMID: 35274381 BACKGROUND

• 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.

  PMID: 12588220 BACKGROUND

• 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.

  PMID: 32796326 BACKGROUND

• 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.

  PMID: 22892283 BACKGROUND

• 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.

  PMID: 24080866 BACKGROUND

• 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.

  PMID: 30502411 BACKGROUND

• 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.

  PMID: 27227423 BACKGROUND

• 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.

  PMID: 12224974 BACKGROUND

• 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.

  PMID: 20800320 BACKGROUND

• 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.

  PMID: 18638628 BACKGROUND

• 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.

  PMID: 21457390 BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms; Postoperative Complications; Recurrence; Carcinoma, Basal Cell; Hutchinson's Melanotic Freckle

Interventions

Mohs Surgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Microsurgery; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures

Study Officials

• K Mosterd, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 28, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

NL (1)