Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-31 @ 11:14 AM
Study NCT ID:
NCT02617706
Status:
WITHDRAWN
Last Update Posted:
2017-08-14
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'financial reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.', 'timeFrame': '30 days', 'description': 'The primary objective of this study is to assess surgical site infection within 30 days of surgery for "high risk" patients undergoing colo-rectal surgery in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control Measures as either yes infection or no infection'}], 'secondaryOutcomes': [{'measure': 'Severity of infection measured with the Southampton Scoring System', 'timeFrame': '30 days', 'description': 'Severity of infection using Southampton Scoring System. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints'}, {'measure': 'Number of days until patients surgical site is healed', 'timeFrame': '30 days', 'description': 'Time to heal. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints'}, {'measure': 'Resource utilization - cost of treatments, hospital stays, bandages, nursing care', 'timeFrame': '30 days', 'description': 'Resource utilization - cost of treatments, hospital stays, bandages, nursing care all measured in dollar amounts and then summed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorectal surgeries', 'infection', 'topical oxygen'], 'conditions': ['Anorectal Surgeries']}, 'descriptionModule': {'briefSummary': 'EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).', 'detailedDescription': 'Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective colo-rectal surgery with or without anastomosis and with or without stoma\n* Patient age: 18-80\n\nExclusion Criteria:\n\n* Pregnancy\n\n * Anesthesiology ASA score of 4 or above\n * fever or existing signs of infection at the time of surgery\n * Diabetes Mellitus type I or II with HbA1C level 12% or more\n * Persons with decubitus or diabetic ulcers\n * Subjects with peritoneal metastases\n * Patients with severe malnutrition as indicated by Prealbumin value of \\<20\n * BMI ≥50'}, 'identificationModule': {'nctId': 'NCT02617706', 'briefTitle': 'Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neogenix, LLC dba Ogenix'}, 'officialTitle': 'A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Standard of Care to Assess Postoperative Wound Infection Rate in Colon and Rectal Resections', 'orgStudyIdInfo': {'id': 'EPF-615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transdermal Continuous Oxygen Therapy', 'description': 'EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care', 'interventionNames': ['Device: Epiflo']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'standard wound care for 4 weeks'}], 'interventions': [{'name': 'Epiflo', 'type': 'DEVICE', 'otherNames': ['TCOT, Transdermal Continuous Oxygen Therapy'], 'description': 'Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.', 'armGroupLabels': ['Transdermal Continuous Oxygen Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Department of General Surgery Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Sarang Sarangapani, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neogenix,LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neogenix, LLC dba Ogenix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}