<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/NCT03816995</url>
  </required_header>
  <id_info>
    <org_study_id>18-1346</org_study_id>
    <nct_id>NCT03816995</nct_id>
  </id_info>
  <brief_title>A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery</brief_title>
  <official_title>A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical site infection (SSI) remains a problem in colorectal surgery. Strategies to reduce&#xD;
      the incidence of SSI following colorectal surgery are important to improve overall patient&#xD;
      outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical&#xD;
      patients.&#xD;
&#xD;
      Preventing contamination of the wound through the use of barrier wound protectors or&#xD;
      intraoperative wound irrigation has shown significant promise individually and is an ongoing&#xD;
      focus to reduce wound infections SSI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery&#xD;
      with published rates ranging from 7 to 25%. The negative outcomes of SSI are well reported&#xD;
      and include a significant increase in morbidity, length of hospital stay, readmissions and&#xD;
      healthcare-associated cost. Therefore, strategies to reduce the incidence of SSI following&#xD;
      colorectal surgery are important to improve overall patient outcomes, reduce&#xD;
      healthcare-associated costs and provide value-based healthcare to surgical patients.&#xD;
&#xD;
      Key to the pathogenesis of SSI is the degree of bacterial contamination of the surgical&#xD;
      wound. Preventing contamination of the wound or reducing the bacterial load through the use&#xD;
      of barrier wound protectors or intraoperative wound irrigation has shown significant promise&#xD;
      individually and is an ongoing strategic focus to reduce wound infections after surgery.&#xD;
&#xD;
      The usage of intraoperative wound irrigation has been shown to significantly reduce the risk&#xD;
      of SSI via multiple RTC. A surgical device that combines continuous wound irrigation and&#xD;
      barrier protection will have an important SSI prevention advantage.&#xD;
&#xD;
      CleanCision is a recently developed apparatus that serves this purpose and was found to&#xD;
      reduce bacterial wound contamination in preclinical and clinical trials.&#xD;
&#xD;
      This study aims to investigate the effect of using CleanCision wound protector on the rates&#xD;
      of postoperative Surgical Site Infections in comparison to the current wound protector&#xD;
      (Alexis O) being used at our institute.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2026</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Site Infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">702</enrollment>
  <condition>Colorectal Surgery</condition>
  <arm_group>
    <arm_group_label>Alexis O Wound Protector</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will undergo standard surgical procedure using the Alexis O wound protector.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CleanCision Wound Protector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CleanCision Wound Retraction and Protection System</intervention_name>
    <description>wound retraction and irrigation</description>
    <arm_group_label>CleanCision Wound Protector</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alexis O Wound Protector</intervention_name>
    <description>wound retraction</description>
    <arm_group_label>Alexis O Wound Protector</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18 years old and above.&#xD;
&#xD;
          2. Elective colorectal surgery with a planned resection including open or laparoscopic&#xD;
             surgeries.&#xD;
&#xD;
          3. Clean -contaminated, contaminated and dirty wounds per the definition above.&#xD;
&#xD;
          4. Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB&#xD;
             and mechanical bowel preparation.&#xD;
&#xD;
          5. Anticipated incision length of 3-17 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients younger than 18 years old.&#xD;
&#xD;
          2. Patients with a preexisting stoma.&#xD;
&#xD;
          3. Patiens with prior laparotomy within 15 days.&#xD;
&#xD;
          4. Patients with an active infection or systemic antibiotic therapy within 1 week prior&#xD;
             to surgery with the exception of preoperative antimicrobial prophylaxis.&#xD;
&#xD;
          5. Emergent/ urgent surgery.&#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>Scott Steele, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Holly Renner</last_name>
    <phone>216-299-9529</phone>
    <email>rennerh@ccf.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cleveland Clinic Main Campus</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Holly M Renner, BS</last_name>
      <phone>216-299-9529</phone>
      <email>rennerh@ccf.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Walz JM, Paterson CA, Seligowski JM, Heard SO. Surgical site infection following bowel surgery: a retrospective analysis of 1446 patients. Arch Surg. 2006 Oct;141(10):1014-8; discussion 1018. doi: 10.1001/archsurg.141.10.1014.</citation>
    <PMID>17043280</PMID>
  </reference>
  <reference>
    <citation>Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. doi: 10.1097/01.sla.0000124292.21605.99.</citation>
    <PMID>15082963</PMID>
  </reference>
  <reference>
    <citation>Konishi T, Watanabe T, Kishimoto J, Nagawa H. Elective colon and rectal surgery differ in risk factors for wound infection: results of prospective surveillance. Ann Surg. 2006 Nov;244(5):758-63. doi: 10.1097/01.sla.0000219017.78611.49.</citation>
    <PMID>17060769</PMID>
  </reference>
  <reference>
    <citation>de Oliveira AC, Ciosak SI, Ferraz EM, Grinbaum RS. Surgical site infection in patients submitted to digestive surgery: risk prediction and the NNIS risk index. Am J Infect Control. 2006 May;34(4):201-7. doi: 10.1016/j.ajic.2005.12.011.</citation>
    <PMID>16679177</PMID>
  </reference>
  <reference>
    <citation>Fujii S, Tsukamoto M, Fukushima Y, Shimada R, Okamoto K, Tsuchiya T, Nozawa K, Matsuda K, Hashiguchi Y. Systematic review of laparoscopic vs open surgery for colorectal cancer in elderly patients. World J Gastrointest Oncol. 2016 Jul 15;8(7):573-82. doi: 10.4251/wjgo.v8.i7.573.</citation>
    <PMID>27559437</PMID>
  </reference>
  <reference>
    <citation>Serra-Aracil X, Garcia-Domingo MI, Pares D, Espin-Basany E, Biondo S, Guirao X, Orrego C, Sitges-Serra A. Surgical site infection in elective operations for colorectal cancer after the application of preventive measures. Arch Surg. 2011 May;146(5):606-12. doi: 10.1001/archsurg.2011.90.</citation>
    <PMID>21576613</PMID>
  </reference>
  <reference>
    <citation>de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.</citation>
    <PMID>19398246</PMID>
  </reference>
  <reference>
    <citation>Tanner J, Khan D, Aplin C, Ball J, Thomas M, Bankart J. Post-discharge surveillance to identify colorectal surgical site infection rates and related costs. J Hosp Infect. 2009 Jul;72(3):243-50. doi: 10.1016/j.jhin.2009.03.021. Epub 2009 May 15.</citation>
    <PMID>19446918</PMID>
  </reference>
  <reference>
    <citation>Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a &quot;high outlier&quot; institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009 Mar;52(3):374-9. doi: 10.1007/DCR.0b013e31819a5e45.</citation>
    <PMID>19333034</PMID>
  </reference>
  <reference>
    <citation>Gorgun E, Rencuzogullari A, Ozben V, Stocchi L, Fraser T, Benlice C, Hull T. An Effective Bundled Approach Reduces Surgical Site Infections in a High-Outlier Colorectal Unit. Dis Colon Rectum. 2018 Jan;61(1):89-98. doi: 10.1097/DCR.0000000000000929.</citation>
    <PMID>29215475</PMID>
  </reference>
  <reference>
    <citation>Sajid MS, Rathore MA, Sains P, Singh KK. A systematic review of clinical effectiveness of wound edge protector devices in reducing surgical site infections in patients undergoing abdominal surgery. Updates Surg. 2017 Mar;69(1):21-28. doi: 10.1007/s13304-017-0415-2. Epub 2017 Jan 25.</citation>
    <PMID>28124278</PMID>
  </reference>
  <reference>
    <citation>Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.</citation>
    <PMID>22265220</PMID>
  </reference>
  <reference>
    <citation>Mueller TC, Loos M, Haller B, Mihaljevic AL, Nitsche U, Wilhelm D, Friess H, Kleeff J, Bader FG. Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Feb;400(2):167-81. doi: 10.1007/s00423-015-1279-x. Epub 2015 Feb 14.</citation>
    <PMID>25681239</PMID>
  </reference>
  <reference>
    <citation>Solomkin J, Gastmeier P, Bischoff P, Latif A, Berenholtz S, Egger M, Allegranzi B. WHO Guidelines to prevent surgical site infections-Authors' reply. Lancet Infect Dis. 2017 Mar;17(3):262-264. doi: 10.1016/S1473-3099(17)30081-6. Epub 2017 Feb 23. No abstract available.</citation>
    <PMID>28244389</PMID>
  </reference>
  <reference>
    <citation>Papaconstantinou HT, Ricciardi R, Margolin DA, Bergamaschi R, Moesinger RC, Lichliter WE, Birnbaum EH. A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery. World J Surg. 2018 Sep;42(9):3000-3007. doi: 10.1007/s00268-018-4568-z.</citation>
    <PMID>29523908</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Scott Steele</investigator_full_name>
    <investigator_title>Department Chair</investigator_title>
  </responsible_party>
  <keyword>wound irrigation</keyword>
  <keyword>cleancision</keyword>
  <keyword>colorectal surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03816995
org study id: 18-1346
nct id: NCT03816995
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Surgical site infection (SSI) remains a problem in colorectal surgery. Strategies to reduce
      the incidence of SSI following colorectal surgery are important to improve overall patient
      outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical
      patients.

      Preventing contamination of the wound through the use of barrier wound protectors or
      intraoperative wound irrigation has shown significant promise individually and is an ongoing
      focus to reduce wound infections SSI.
Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery
      with published rates ranging from 7 to 25%. The negative outcomes of SSI are well reported
      and include a significant increase in morbidity, length of hospital stay, readmissions and
      healthcare-associated cost. Therefore, strategies to reduce the incidence of SSI following
      colorectal surgery are important to improve overall patient outcomes, reduce
      healthcare-associated costs and provide value-based healthcare to surgical patients.

      Key to the pathogenesis of SSI is the degree of bacterial contamination of the surgical
      wound. Preventing contamination of the wound or reducing the bacterial load through the use
      of barrier wound protectors or intraoperative wound irrigation has shown significant promise
      individually and is an ongoing strategic focus to reduce wound infections after surgery.

      The usage of intraoperative wound irrigation has been shown to significantly reduce the risk
      of SSI via multiple RTC. A surgical device that combines continuous wound irrigation and
      barrier protection will have an important SSI prevention advantage.

      CleanCision is a recently developed apparatus that serves this purpose and was found to
      reduce bacterial wound contamination in preclinical and clinical trials.

      This study aims to investigate the effect of using CleanCision wound protector on the rates
      of postoperative Surgical Site Infections in comparison to the current wound protector
      (Alexis O) being used at our institute.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Surgical Site Infection rate
time frame: 30 days
description: To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector.
arm group label: Alexis O Wound Protector
arm group type: Active Comparator
description: Participants will undergo standard surgical procedure using the Alexis O wound protector.
arm group label: CleanCision Wound Protector
arm group type: Experimental
description: Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
intervention type: Device
intervention name: CleanCision Wound Retraction and Protection System
description: wound retraction and irrigation
arm group label: CleanCision Wound Protector
intervention type: Device
intervention name: Alexis O Wound Protector
description: wound retraction
arm group label: Alexis O Wound Protector
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Steele, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Holly Renner
phone: 216-299-9529
email: rennerh@ccf.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Walz JM, Paterson CA, Seligowski JM, Heard SO. Surgical site infection following bowel surgery: a retrospective analysis of 1446 patients. Arch Surg. 2006 Oct;141(10):1014-8; discussion 1018. doi: 10.1001/archsurg.141.10.1014.
PMID: 17043280
citation: Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. doi: 10.1097/01.sla.0000124292.21605.99.
PMID: 15082963
citation: Konishi T, Watanabe T, Kishimoto J, Nagawa H. Elective colon and rectal surgery differ in risk factors for wound infection: results of prospective surveillance. Ann Surg. 2006 Nov;244(5):758-63. doi: 10.1097/01.sla.0000219017.78611.49.
PMID: 17060769
citation: de Oliveira AC, Ciosak SI, Ferraz EM, Grinbaum RS. Surgical site infection in patients submitted to digestive surgery: risk prediction and the NNIS risk index. Am J Infect Control. 2006 May;34(4):201-7. doi: 10.1016/j.ajic.2005.12.011.
PMID: 16679177
citation: Fujii S, Tsukamoto M, Fukushima Y, Shimada R, Okamoto K, Tsuchiya T, Nozawa K, Matsuda K, Hashiguchi Y. Systematic review of laparoscopic vs open surgery for colorectal cancer in elderly patients. World J Gastrointest Oncol. 2016 Jul 15;8(7):573-82. doi: 10.4251/wjgo.v8.i7.573.
PMID: 27559437
citation: Serra-Aracil X, Garcia-Domingo MI, Pares D, Espin-Basany E, Biondo S, Guirao X, Orrego C, Sitges-Serra A. Surgical site infection in elective operations for colorectal cancer after the application of preventive measures. Arch Surg. 2011 May;146(5):606-12. doi: 10.1001/archsurg.2011.90.
PMID: 21576613
citation: de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
PMID: 19398246
citation: Tanner J, Khan D, Aplin C, Ball J, Thomas M, Bankart J. Post-discharge surveillance to identify colorectal surgical site infection rates and related costs. J Hosp Infect. 2009 Jul;72(3):243-50. doi: 10.1016/j.jhin.2009.03.021. Epub 2009 May 15.
PMID: 19446918
citation: Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a "high outlier" institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009 Mar;52(3):374-9. doi: 10.1007/DCR.0b013e31819a5e45.
PMID: 19333034
citation: Gorgun E, Rencuzogullari A, Ozben V, Stocchi L, Fraser T, Benlice C, Hull T. An Effective Bundled Approach Reduces Surgical Site Infections in a High-Outlier Colorectal Unit. Dis Colon Rectum. 2018 Jan;61(1):89-98. doi: 10.1097/DCR.0000000000000929.
PMID: 29215475
citation: Sajid MS, Rathore MA, Sains P, Singh KK. A systematic review of clinical effectiveness of wound edge protector devices in reducing surgical site infections in patients undergoing abdominal surgery. Updates Surg. 2017 Mar;69(1):21-28. doi: 10.1007/s13304-017-0415-2. Epub 2017 Jan 25.
PMID: 28124278
citation: Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.
PMID: 22265220
citation: Mueller TC, Loos M, Haller B, Mihaljevic AL, Nitsche U, Wilhelm D, Friess H, Kleeff J, Bader FG. Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Feb;400(2):167-81. doi: 10.1007/s00423-015-1279-x. Epub 2015 Feb 14.
PMID: 25681239
citation: Solomkin J, Gastmeier P, Bischoff P, Latif A, Berenholtz S, Egger M, Allegranzi B. WHO Guidelines to prevent surgical site infections-Authors' reply. Lancet Infect Dis. 2017 Mar;17(3):262-264. doi: 10.1016/S1473-3099(17)30081-6. Epub 2017 Feb 23. No abstract available.
PMID: 28244389
citation: Papaconstantinou HT, Ricciardi R, Margolin DA, Bergamaschi R, Moesinger RC, Lichliter WE, Birnbaum EH. A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery. World J Surg. 2018 Sep;42(9):3000-3007. doi: 10.1007/s00268-018-4568-z.
PMID: 29523908
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Scott Steele
investigator title: Department Chair
mesh term: Surgical Wound Infection
sharing ipd: No