Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT03907306
Status:
UNKNOWN
Last Update Posted:
2019-04-08
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014945', 'term': 'Wound Healing'}], 'ancestors': [{'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '30 days', 'description': 'Total wound healing will be assessed with the help of cytological and macroscopic methods.In the cytological method the presence of fibroblasts, mature epithelial cells, scar tissue formation and the absence of inflammation will be the criterion of wound healing, as well as the presence of macroscopic features of wound epithelialization.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity Measure', 'timeFrame': '2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days', 'description': 'Visual analogue scale (0-10 points)'}, {'measure': 'Life quality', 'timeFrame': 'before operation, 8 days, 30 days', 'description': 'Short Form - 36 Health Status Survey'}, {'measure': 'Microbiological contamination of wound area', 'timeFrame': '2, 8, 14, 21, 30 days', 'description': 'Microbiological contamination from the post operation wound area. The assessment of CAP effect on bacteria in planktonic and biofilm forms. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cold argon plasma', 'hemorrhoidectomy', 'wound healing', 'hemorrhoids'], 'conditions': ['Cold Argon Plasma']}, 'descriptionModule': {'briefSummary': 'This is single-center, prospective, randomized study', 'detailedDescription': 'This study will include patients with 3-4 stage hemorrhoids. They will undergo an operation of open hemorrhoidectomy. Patients will be divided into a study group and a control group. Study group patients during a post-operation period except a standard treatment (antiseptic solutions and antibacterial and wound healing ointments) of a post-operation wound will be treated with cold argon plasma. Control group patients will be treated with a standard treatment. Wound healing speed will be researched.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3-4 stage hemorrhoids\n* 3 hemorrhoids\n\nExclusion Criteria:\n\n* patients underwent anal canals intervention\n* acute hemorrhoids\n* inflammatory bowel disease\n* co-morbidity diseases of anal canal and perianal area\n* concurrent conditions in the stage of decompensation'}, 'identificationModule': {'nctId': 'NCT03907306', 'briefTitle': 'Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'State Scientific Centre of Coloproctology, Russian Federation'}, 'officialTitle': 'Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy', 'orgStudyIdInfo': {'id': '120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients after open hemorrhoidectomy (study group)', 'description': 'Patients to whom during a post-operation period cold argon plasma and a standard treatment will be treated. Cold argon plasma will be applied during 4 minutes at one session on the 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 14th, 21nd, 30th day after operation. The usage of antibacterial and wound healing ointments daily.', 'interventionNames': ['Procedure: Wound healing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients after open hemorrhoidectomy (control group)', 'description': 'Patients who during a post-operation period will be treated with a standard treatment.The usage of antibacterial and wound healing ointments daily.', 'interventionNames': ['Procedure: Wound healing']}], 'interventions': [{'name': 'Wound healing', 'type': 'PROCEDURE', 'description': 'The measurement of a wound area is committed on the 2nd, 8th, 14th, 21nd and 30th day after operation. By means of the mathematical formulas the wound healing speed will be defined. The wound process will be researched with the help of cytological method. The wound prints will be taken on the 2nd, 8th, 14th, 21nd and 30th day after operation. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once). The pain assessment will be measured by a visual analogue scale on the 2nd, 3rd,4th, 5th, 6th, 7th, 8th, 14th, 21nd and 30th day after operation. The life quality will be researched by means of Health Status Survey on the 8th and 30th day before operation.', 'armGroupLabels': ['Patients after open hemorrhoidectomy (control group)', 'Patients after open hemorrhoidectomy (study group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123423', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'State Scientific Centre of Coloproctology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Nikita V. Tuktagulov', 'role': 'CONTACT', 'email': 'dr.tuktagulov@gmail.com', 'phone': '+7 926 188 31 29'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Scientific Centre of Coloproctology, Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}