<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/NCT03765060</url>
  </required_header>
  <id_info>
    <org_study_id>SL-Stitch</org_study_id>
    <nct_id>NCT03765060</nct_id>
  </id_info>
  <brief_title>The Efficacy and Security of the Small Stitch Technique in Emergency Surgery</brief_title>
  <acronym>STCU</acronym>
  <official_title>Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</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>
      This study evaluates the abdominal closure technique in emergency surgery. Half of&#xD;
      participants will be perform the classic Large Stitch technique, while the other half will&#xD;
      undergo the Small Stitch technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The closure of laparotomy is one of the most important challenges facing the surgeon.&#xD;
&#xD;
      The classic technique of wall closure is the Large Stitch technique that uses monofilament&#xD;
      double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to&#xD;
      the alba line and between each stitch of 1 cm.&#xD;
&#xD;
      Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of&#xD;
      laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable&#xD;
      synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26&#xD;
      needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of&#xD;
      separation between stitches.&#xD;
&#xD;
      There are very few studies about the role of Small Stitch technique in the field of Emergency&#xD;
      Surgery where the increased morbidity of the patient and the higher rate of surgical wound&#xD;
      infection can play a fundamental role, and could be improved with the use of new abdominal&#xD;
      wall closure techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the small stitch technique defined by eventration rate</measure>
    <time_frame>1 year</time_frame>
    <description>To determine the efficacy of the &quot;Small stitch&quot; technique versus the &quot;Large Stitch&quot; technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the small stitch technique defined by local complications rate</measure>
    <time_frame>1 year</time_frame>
    <description>To determine whether the closure of midline laparotomy with the &quot;Small Stitch&quot; technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the small stitch technique defined by evisceration rate</measure>
    <time_frame>1 year</time_frame>
    <description>To determine if the closure of the midline laparotomy with the &quot;Small Stitch&quot; technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the small stitch technique defined by improvement of quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>To determine if the closure of a midline laparotomy with the &quot;Small Stitch&quot; technique in patients undergoing urgent abdominal surgery improves the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Security of the small stitch technique</measure>
    <time_frame>1 year</time_frame>
    <description>To determine the safety of the Small Stitch technique versus the &quot;Large Stitch&quot; technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Abdominal Wall Defect</condition>
  <condition>Abdominal Wall Hernia</condition>
  <condition>Eventration</condition>
  <condition>Evisceration; Operation Wound</condition>
  <arm_group>
    <arm_group_label>Small Stitch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients requiring an urgent emergency laparotomy. The Small Stitch closure technique will be perform using a Monomax® 2/0 HR26 (Half-circle Round body):&#xD;
It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle (Half-circle Round body).&#xD;
In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Large Stitch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention will be the classic large Stitch closure technique using a Monomax® 1 HR48 (Half-circle Round body).&#xD;
It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle (Half-circle Round body).&#xD;
In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Monomax® 2/0 HR26</intervention_name>
    <description>It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle.&#xD;
In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.</description>
    <arm_group_label>Small Stitch</arm_group_label>
    <other_name>Suture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Monomax® 1 HR48</intervention_name>
    <description>It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle.&#xD;
In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.</description>
    <arm_group_label>Large Stitch</arm_group_label>
    <other_name>Suture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients over 18 years of age and who provide informed consent to participate in the&#xD;
             study.&#xD;
&#xD;
          2. Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior midline laparotomy.&#xD;
&#xD;
          2. Patients with BMI&gt; 45 kg / m2&#xD;
&#xD;
          3. Patients with ASA (American Society of Anesthesiologists)&gt; IV.&#xD;
&#xD;
          4. Patient with an advanced terminal illness with an expectation of life &lt;1 year.&#xD;
&#xD;
          5. Patients with abdominal aortic aneurysm.&#xD;
&#xD;
          6. Patients with coagulopathy: patient previously diagnosed with von Willebrand disease,&#xD;
             hemophilia or Immune thrombocytopenic purpura.&#xD;
&#xD;
          7. Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or&#xD;
             immunosuppressive treatment.&#xD;
&#xD;
          8. Patients with collagen pathology: patient previously diagnosed with Marfan syndrome,&#xD;
             Ehlers-Danlos syndrome, homocystinuria and scleroderma.&#xD;
&#xD;
          9. Chemotherapeutic treatment 2 weeks before surgery.&#xD;
&#xD;
         10. Radiotherapy treatment 6 weeks before surgery.&#xD;
&#xD;
         11. Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids&#xD;
             prior to surgery or during the surgical process.&#xD;
&#xD;
         12. Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant,&#xD;
             or those who do not wish to use effective contraception (hormonal contraceptives&#xD;
             (implantation, patches, oral), and double barrier methods (any double combination of:&#xD;
             IUD (intrauterine device), male or female prophylactics with spermicidal gel,&#xD;
             diaphragm, contraceptive sponge, cervical cap).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamayo López María Jesús, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Padillo Ruiz Francisco Javier, PhD</last_name>
    <role>Study Director</role>
    <affiliation>HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tamayo López María Jesús, PhD</last_name>
    <phone>686589986</phone>
    <email>mtamayolopez@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tallón Aguilar Luis, MD</last_name>
    <phone>653393951</phone>
    <email>ltallona@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mª Jesús Tamayo lópez, PhD</last_name>
      <phone>34955013414</phone>
      <email>mtamayolopez@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Luis Tallón Aguilar</last_name>
      <email>ltallona@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.</citation>
    <PMID>23143146</PMID>
  </reference>
  <reference>
    <citation>Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30.</citation>
    <PMID>21279664</PMID>
  </reference>
  <reference>
    <citation>Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10.</citation>
    <PMID>23839330</PMID>
  </reference>
  <reference>
    <citation>O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. doi: 10.1016/s1479-666x(03)80004-5.</citation>
    <PMID>15568420</PMID>
  </reference>
  <reference>
    <citation>Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. doi: 10.1002/bjs.1800801020.</citation>
    <PMID>8242299</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03765060
org study id: SL-Stitch
nct id: NCT03765060
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the abdominal closure technique in emergency surgery. Half of
      participants will be perform the classic Large Stitch technique, while the other half will
      undergo the Small Stitch technique.
The closure of laparotomy is one of the most important challenges facing the surgeon.

      The classic technique of wall closure is the Large Stitch technique that uses monofilament
      double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to
      the alba line and between each stitch of 1 cm.

      Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of
      laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable
      synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26
      needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of
      separation between stitches.

      There are very few studies about the role of Small Stitch technique in the field of Emergency
      Surgery where the increased morbidity of the patient and the higher rate of surgical wound
      infection can play a fundamental role, and could be improved with the use of new abdominal
      wall closure techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Efficacy of the small stitch technique defined by eventration rate
time frame: 1 year
description: To determine the efficacy of the "Small stitch" technique versus the "Large Stitch" technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery.
measure: Efficacy of the small stitch technique defined by local complications rate
time frame: 1 year
description: To determine whether the closure of midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection.
measure: Efficacy of the small stitch technique defined by evisceration rate
time frame: 1 year
description: To determine if the closure of the midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration.
measure: Efficacy of the small stitch technique defined by improvement of quality of life
time frame: 1 year
description: To determine if the closure of a midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery improves the quality of life.
measure: Security of the small stitch technique
time frame: 1 year
description: To determine the safety of the Small Stitch technique versus the "Large Stitch" technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study.
arm group label: Small Stitch
arm group type: Experimental
description: Patients requiring an urgent emergency laparotomy. The Small Stitch closure technique will be perform using a Monomax® 2/0 HR26 (Half-circle Round body):
It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle (Half-circle Round body).
In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.
arm group label: Large Stitch
arm group type: Active Comparator
description: The intervention will be the classic large Stitch closure technique using a Monomax® 1 HR48 (Half-circle Round body).
It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle (Half-circle Round body).
In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.
intervention type: Procedure
intervention name: Monomax® 2/0 HR26
description: It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle.
In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.
arm group label: Small Stitch
other name: Suture
intervention type: Procedure
intervention name: Monomax® 1 HR48
description: It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle.
In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.
arm group label: Large Stitch
other name: Suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tamayo López María Jesús, PhD
role: Principal Investigator
affiliation: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
last name: Padillo Ruiz Francisco Javier, PhD
role: Study Director
affiliation: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
last name: Tamayo López María Jesús, PhD
phone: 686589986
email: mtamayolopez@gmail.com
last name: Tallón Aguilar Luis, MD
phone: 653393951
email: ltallona@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
citation: Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.
PMID: 23143146
citation: Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30.
PMID: 21279664
citation: Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10.
PMID: 23839330
citation: O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. doi: 10.1016/s1479-666x(03)80004-5.
PMID: 15568420
citation: Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. doi: 10.1002/bjs.1800801020.
PMID: 8242299
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Hernia, Abdominal
mesh term: Hernia, Ventral
mesh term: Internal Hernia