Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-11 @ 7:35 AM
Study NCT ID:
NCT00978133
Status:
TERMINATED
Last Update Posted:
2018-04-18
First Post:
2009-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DERMABOND ProPen in Closure of Colectomy Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100832', 'term': 'octyl 2-cyanoacrylate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'whyStopped': 'Difficulty in accrual of study subjects, small numbers of potential subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2009-09-14', 'studyFirstSubmitQcDate': '2009-09-14', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '3 months'}, {'measure': 'Patient satisfaction', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Superficial surgical site infections', 'timeFrame': '3 months'}, {'measure': 'Time taken for wound closure', 'timeFrame': 'Intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colectomy', 'Closure', 'Wound', 'Dermabond', 'Propen'], 'conditions': ['Wound']}, 'referencesModule': {'references': [{'pmid': '9832658', 'type': 'BACKGROUND', 'citation': 'Quinn J, Wells G, Sutcliffe T, Jarmuske M, Maw J, Stiell I, Johns P. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998 Dec;32(6):645-9. doi: 10.1016/s0196-0644(98)70061-7.'}, {'pmid': '15450839', 'type': 'BACKGROUND', 'citation': 'Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. doi: 10.1016/j.amjsurg.2004.04.006.'}]}, 'descriptionModule': {'briefSummary': '2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. Here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-OCA, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the Department of Colorectal Surgery, Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective colectomies for benign or malignant conditions\n* Midline vertical incisions or skin crease incisions\n* Above the age of 21 years old\n* Able to make own valid informed decisions\n\nExclusion Criteria:\n\n* Patients undergoing surgery for recurrent or metastatic disease\n* Surgery for surgical emergencies such as acute abdomen or bleeding\n* Known allergy to DERMABOND ProPen Tissue Adhesive or any of its constituents (cyanoacrylate or formaldehyde)\n* Patients on immunosuppression'}, 'identificationModule': {'nctId': 'NCT00978133', 'briefTitle': 'Study of DERMABOND ProPen in Closure of Colectomy Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Prospective Randomized Study to Evaluate the Use of DERMABOND ProPen (2-octylcyanoacrylate) in the Closure of Abdominal Wounds Versus Closure With Skin Staples in Patients Undergoing Elective Colectomy.', 'orgStudyIdInfo': {'id': 'Dermabond colectomy wounds'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Skin Staples', 'description': 'Skin closure with skin staples', 'interventionNames': ['Procedure: Skin closure with skin staples']}, {'type': 'EXPERIMENTAL', 'label': 'Dermabond', 'description': 'Closure of abdominal wound with dermabond (2-octylcyanoacrylate)', 'interventionNames': ['Procedure: Dermabond ProPen (2-octylcyanoacrylate)']}], 'interventions': [{'name': 'Dermabond ProPen (2-octylcyanoacrylate)', 'type': 'PROCEDURE', 'otherNames': ['Dermabond ProPen'], 'description': 'Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers', 'armGroupLabels': ['Dermabond']}, {'name': 'Skin closure with skin staples', 'type': 'PROCEDURE', 'description': 'Skin closure with skin staples', 'armGroupLabels': ['Skin Staples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Julian KP Ong, FRCSEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}, {'name': 'Kok-Sun Ho, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}