Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT03816995
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brienzr@ccf.org', 'phone': '216-399-9186', 'title': 'Rita Brienza', 'organization': 'The Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days following surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Alexis O Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the Alexis O wound protector.\n\nAlexis O Wound Protector: wound retraction', 'otherNumAtRisk': 327, 'deathsNumAtRisk': 327, 'otherNumAffected': 98, 'seriousNumAtRisk': 327, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CleanCision Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System\n\nCleanCision Wound Retraction and Protection System: wound retraction and irrigation', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 318, 'otherNumAffected': 95, 'seriousNumAtRisk': 318, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post-Op Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Unplanned Intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Anastomotic Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op C.Diff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned Reoperation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-Op Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgical Site Infection (SSI) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alexis O Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the Alexis O wound protector.\n\nAlexis O Wound Protector: wound retraction'}, {'id': 'OG001', 'title': 'CleanCision Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System\n\nCleanCision Wound Retraction and Protection System: wound retraction and irrigation'}], 'classes': [{'title': 'Post-op Superficial SSI', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Post-op Deep SSI', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Post-op Organ/Space SSI', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Composite Infection (SSIs + Wound Disruption)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alexis O Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the Alexis O wound protector.\n\nAlexis O Wound Protector: wound retraction'}, {'id': 'FG001', 'title': 'CleanCision Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System\n\nCleanCision Wound Retraction and Protection System: wound retraction and irrigation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '351'}, {'groupId': 'FG001', 'numSubjects': '351'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '318'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Cancelled Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'No wound protector used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alexis O Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the Alexis O wound protector.\n\nAlexis O Wound Protector: wound retraction'}, {'id': 'BG001', 'title': 'CleanCision Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System\n\nCleanCision Wound Retraction and Protection System: wound retraction and irrigation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.1', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '16.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-26', 'size': 262415, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-14T20:45', 'hasProtocol': True}, {'date': '2022-11-07', 'size': 214126, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-15T14:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 702}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2019-01-23', 'resultsFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-21', 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection (SSI) Rate', 'timeFrame': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['wound irrigation', 'cleancision', 'colorectal surgery'], 'conditions': ['Colorectal Surgery']}, 'referencesModule': {'references': [{'pmid': '17043280', 'type': 'BACKGROUND', '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': '15082963', 'type': 'BACKGROUND', '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': '17060769', 'type': 'BACKGROUND', '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': '16679177', 'type': 'BACKGROUND', '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': '27559437', 'type': 'BACKGROUND', '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': '21576613', 'type': 'BACKGROUND', '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': '19398246', 'type': 'BACKGROUND', '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': '19446918', 'type': 'BACKGROUND', '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': '19333034', 'type': 'BACKGROUND', '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': '29215475', 'type': 'BACKGROUND', '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': '28124278', 'type': 'BACKGROUND', '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': '22265220', 'type': 'BACKGROUND', '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': '25681239', 'type': 'BACKGROUND', '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': '28244389', 'type': 'BACKGROUND', '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': '29523908', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPreventing 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.', 'detailedDescription': '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.\n\nKey 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.\n\nThe 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.\n\nCleanCision is a recently developed apparatus that serves this purpose and was found to reduce bacterial wound contamination in preclinical and clinical trials.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 18 years old and above.\n2. Elective colorectal surgery with a planned resection including open or laparoscopic surgeries.\n3. Clean -contaminated, contaminated and dirty wounds per the definition above.\n4. Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB and mechanical bowel preparation.\n5. Anticipated incision length of 3-17 cm\n\nExclusion Criteria:\n\n1. Patients younger than 18 years old.\n2. Patients with a preexisting stoma.\n3. Patients with prior laparotomy within 15 days.\n4. Patients with an active infection or systemic antibiotic therapy within 1 week prior to surgery with the exception of preoperative antimicrobial prophylaxis.\n5. Emergent/ urgent surgery.'}, 'identificationModule': {'nctId': 'NCT03816995', 'briefTitle': 'Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery', 'orgStudyIdInfo': {'id': '18-1346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alexis O Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the Alexis O wound protector.', 'interventionNames': ['Device: Alexis O Wound Protector']}, {'type': 'EXPERIMENTAL', 'label': 'CleanCision Wound Protector', 'description': 'Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System', 'interventionNames': ['Device: CleanCision Wound Retraction and Protection System']}], 'interventions': [{'name': 'CleanCision Wound Retraction and Protection System', 'type': 'DEVICE', 'description': 'wound retraction and irrigation', 'armGroupLabels': ['CleanCision Wound Protector']}, {'name': 'Alexis O Wound Protector', 'type': 'DEVICE', 'description': 'wound retraction', 'armGroupLabels': ['Alexis O Wound Protector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Main Campus', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Scott Steele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scott Steele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prescient Surgical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'President, Main Campus Submarket', 'investigatorFullName': 'Scott Steele', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}