Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT06872151
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of a Topical Medical Device in Wound Healing and Symptom Relief in the Postoperative Period of Open Excisional Hemorrhoidectomy (The Emor Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D012837', 'term': 'Silver Sulfadiazine'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013411', 'term': 'Sulfadiazine'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-28', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of epithelialization', 'timeFrame': 'From baseline to visit 3 (40 days after the start of the treatment)', 'description': 'The degree of epithelialization of the fissure was determined at each visit and stratified using 3 levels (1 to 3) corresponding to:\n\n1. \\< 50%\n2. \\> 50%\n3. 100% (complete healing)'}], 'secondaryOutcomes': [{'measure': 'Burning and pain', 'timeFrame': 'From baseline to visit 3 (40 days after the start of the treatment)', 'description': 'Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)'}, {'measure': 'Itching', 'timeFrame': 'From baseline to visit 3 (40 days after the start of the treatment)', 'description': 'Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)'}, {'measure': 'Bowel movements', 'timeFrame': 'At visit 3 (40 days after the start of the treatment)', 'description': 'Bristol Scale (minimum score =1, maximum score =7)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemorrhoids', 'epithelialization', 'Anal diseases', 'hemorrhoidectomy'], 'conditions': ['Anus Diseases', 'Gastrointestinal Diseases', 'Intestinal Diseases', 'Cicatrization', 'Hemorrhoids', 'Hemorrhoids Third Degree']}, 'descriptionModule': {'briefSummary': 'This multicenter randomized controlled phase IV trial aims to compare the clinical efficacy of a gel containing a Propionibacterium extract and a gel with hyaluronic acid and silver sulfadiazine in the degree of epithelialization of post-operative wounds of open excisional hemorrhoidectomy.\n\nThe main questions it aims to answer are:\n\n* To compare the efficacy of the two medical devices in the degree of epithelialization in the postoperative period of open excisional hemorrhoidectomy, at 0, 10, 20 and 40 days from the beginning of treatment.\n* To evaluate the effectiveness of these devices in alleviating: pain, itching, burning, and the type of bowel habit Participants will be randomized, at the beginning of the study, to one of the two treatments, and the efficacy of the two medical devices will be evaluated at 0, 10, 20 and 40 days from the start of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open excisional hemorrhoidectomy, with removal of at least 3 groups\n* Age between 18 and 75 years\n\nExclusion Criteria:\n\n* Patients who do not consent to the study\n* Opioid-dependent patients, chronic use of analgesics\n* Fecal incontinence\n* Anorectal neoplasms\n* Immunosuppressive treatments (e.g., chemotherapy, radiotherapy, etc.)\n* Chronic inflammatory bowel diseases\n* Pregnancy\n* Patients with major psychiatric disorders\n* Known allergy to the components of the treatments under study'}, 'identificationModule': {'nctId': 'NCT06872151', 'briefTitle': 'Evaluation of the Effectiveness of a Topical Medical Device in Wound Healing and Symptom Relief in the Postoperative Period of Open Excisional Hemorrhoidectomy (The Emor Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Evaluation of the Effectiveness of a Gel Containing a Propionibacterium Extract in Wound Healing and Symptom Relief, Such as Pain, Itching, and Burning, in the Postoperative Period of Open Excisional Hemorrhoidectomy', 'orgStudyIdInfo': {'id': 'TheHemorrStudy_Vers_05_02_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gel containing a Propionibacterium extract', 'interventionNames': ['Device: Gel containing a Propionibacterium extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid and silver sulfadiazine', 'interventionNames': ['Drug: Hyaluronic acid and silver sulfadiazine']}], 'interventions': [{'name': 'Gel containing a Propionibacterium extract', 'type': 'DEVICE', 'description': 'Patients will apply 1 ml of gel (equal to one phalanx) twice a day for 20 days, manually at the anal level and in the perianal area. In the morning, after defecation and in the evening before going to bed.', 'armGroupLabels': ['Gel containing a Propionibacterium extract']}, {'name': 'Hyaluronic acid and silver sulfadiazine', 'type': 'DRUG', 'description': 'Patients will apply 1ml of gel (equal to a phalanx) twice a day for 20 days, manually at the anal level and in the perianal area. In the morning, after defecation and in the evening before going to bed.', 'armGroupLabels': ['Hyaluronic acid and silver sulfadiazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09042', 'city': 'Monserrato', 'state': 'Cagliari', 'country': 'Italy', 'facility': 'Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}], 'overallOfficials': [{'name': 'Deidda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cagliari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Policlinico Umberto I', 'class': 'OTHER'}, {'name': 'Hospital San Pietro Fatebenefratelli', 'class': 'OTHER'}, {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, {'name': 'ASL Roma 6', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Simona Deidda', 'investigatorAffiliation': 'University of Cagliari'}}}}