Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014619
• Other study ID #: 2023-0043
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Maastricht University Medical Center
• Contact: Emmy Cruts, MD
• Phone: +31(0)43 3877295
• Email: e.cruts[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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+.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Mohs surgery
Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).
• Slow Mohs surgery
Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Within 1 month after completion of the surgical intervention.
Secondary	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.	Up to 5 year after completion of the surgical intervention.