xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014619</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0043</org_study_id>
      <nct_id>NCT06014619</nct_id>
    </id_info>
    <brief_title>Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs</brief_title>
    <official_title>Clinical Presentation and Surgical Outcomes in Patients With Skin Disorders Treated With Mohs Micrographic Surgery and Slow Mohs.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types&#xD;
        of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna&#xD;
        (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of&#xD;
        micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both&#xD;
        in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims&#xD;
        to investigate the clinical presentation and outcomes (i.e. complications and recurrence&#xD;
        rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the&#xD;
        Maastricht University Medical Center+ in Maastricht, the Netherlands.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of complications</measure>
      <time_frame>Within 1 month after completion of the surgical intervention.</time_frame>
      <description>The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of recurrence</measure>
      <time_frame>Up to 5 year after completion of the surgical intervention.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hazard ratio of predisposing factors for complications</measure>
      <time_frame>Within 1 month after completion of the surgical intervention.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hazard ratio of predisposing factors for recurrence</measure>
      <time_frame>Up to 5 year after completion of the surgical intervention.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Skin Cancer</condition>
    <condition>Complication</condition>
    <condition>Complication of Surgical Procedure</condition>
    <condition>Complication,Postoperative</condition>
    <condition>Recurrence</condition>
    <condition>Recurrent Disease</condition>
    <condition>Cutaneous Squamous Cell Carcinoma</condition>
    <condition>Basal Cell Carcinoma</condition>
    <condition>Lentigo Maligna</condition>
    <condition>Lentigo Maligna Melanoma</condition>
    <arm_group>
      <arm_group_label>Mohs Micrographic Surgery</arm_group_label>
      <description>Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Slow Mohs</arm_group_label>
      <description>Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Mohs surgery</intervention_name>
      <description>Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).</description>
      <arm_group_label>Mohs Micrographic Surgery</arm_group_label>
      <other_name>Mohs micrographic surgery</other_name>
      <other_name>MMS</other_name>
      <other_name>Mohs</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Slow Mohs surgery</intervention_name>
      <description>Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).</description>
      <arm_group_label>Slow Mohs</arm_group_label>
      <other_name>Slow Mohs</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated with&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with a cutaneous lesion with an indication for Mohs micrographic surgery or&#xD;
               Slow Mohs&#xD;
  &#xD;
            -  patients who received a treatment with either Mohs or Slow Mohs between 1 july 2017&#xD;
               and 1 july 2023 at the dermatology department of the Maastricht University Medical&#xD;
               Center+.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>K Mosterd, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emmy Cruts, MD</last_name>
      <phone>+31(0)43 3877295</phone>
      <email>e.cruts@mumc.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Maastricht University Medical Center+</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>E Cruts, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>30199574</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35274381</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>12588220</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32796326</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>22892283</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>24080866</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>30502411</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27227423</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>12224974</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>20800320</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>18638628</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21457390</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Clinical presentation</keyword>
    <keyword>Outcomes</keyword>
    <keyword>Mohs micrographic surgery</keyword>
    <keyword>Slow Mohs</keyword>
    <keyword>Micrographic surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Basal Cell</mesh_term>
      <mesh_term>Hutchinson's Melanotic Freckle</mesh_term>
      <mesh_term>Lentigo</mesh_term>
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014619
  org study id: 2023-0043
  nct id: NCT06014619
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Retrospective
  measure: Incidence of complications
  time frame: Within 1 month after completion of the surgical intervention.
  description: The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.
  measure: Incidence of recurrence
  time frame: Up to 5 year after completion of the surgical intervention.
  description: 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.
  measure: Hazard ratio of predisposing factors for complications
  time frame: Within 1 month after completion of the surgical intervention.
  description: 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.
  measure: Hazard ratio of predisposing factors for recurrence
  time frame: Up to 5 year after completion of the surgical intervention.
  description: 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.
  arm group label: Mohs Micrographic Surgery
  description: Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands
  arm group label: Slow Mohs
  description: Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands
  intervention type: Procedure
  intervention name: Mohs surgery
  description: Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).
  arm group label: Mohs Micrographic Surgery
  other name: Mohs micrographic surgery
  other name: MMS
  other name: Mohs
  intervention type: Procedure
  intervention name: Slow Mohs surgery
  description: Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).
  arm group label: Slow Mohs
  other name: Slow Mohs
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: K Mosterd, MD, PhD
  role: Principal Investigator
  affiliation: Maastricht University Medical Center
  last name: Emmy Cruts, MD
  phone: +31(0)43 3877295
  email: e.cruts@mumc.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  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.
  PMID: 30199574
  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.
  PMID: 35274381
  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.
  PMID: 12588220
  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.
  PMID: 32796326
  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.
  PMID: 22892283
  citation: 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
  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.
  PMID: 30502411
  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.
  PMID: 27227423
  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.
  PMID: 12224974
  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.
  PMID: 20800320
  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.
  PMID: 18638628
  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.
  PMID: 21457390
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Basal Cell
  mesh term: Hutchinson's Melanotic Freckle
  mesh term: Lentigo
  mesh term: Recurrence
  mesh term: Postoperative Complications
  sharing ipd: Undecided