Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-17 @ 4:41 PM
Study NCT ID:
NCT03791294
Status:
UNKNOWN
Last Update Posted:
2019-01-02
First Post:
2018-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy ( ISTIAB-0)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-29', 'studyFirstSubmitDate': '2018-12-28', 'studyFirstSubmitQcDate': '2018-12-29', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal bleeding', 'timeFrame': 'At the 30th post operative day', 'description': 'at least one episode of red vaginal blood loss'}, {'measure': 'Vaginal vault infection', 'timeFrame': 'At the 30th post operative day', 'description': 'at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy'}, {'measure': 'Urinary tract infection', 'timeFrame': 'At the 30th post operative day', 'description': 'at least one episode of signs and symptoms requiring empiric antibiotic therapy'}, {'measure': 'Dehiscence of vaginal vault suture', 'timeFrame': 'At the 30th post operative day', 'description': 'Dehiscence of vaginal vault suture requiring repeat surgery'}, {'measure': 'Readmission', 'timeFrame': 'At the 30th post operative day', 'description': 'At least one episode of readmission related to postoperative complications'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'At the 30th post operative day', 'description': 'Adverse events due to the use of vaginal capsule therapy: erythema, vaginal and vulvar pruritus, dermatitis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection', 'Bleeding', 'Complication, Postoperative']}, 'descriptionModule': {'briefSummary': 'Total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. The postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. The most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. The introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. In this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications.\n\nThe cationic silver ions (Ag +) stabilized by covalent link with Titanium dioxide (TiO2), the TIAB, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. Thanks to these properties, TIAB is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. Re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. In addition to microbicidal and disruptive biofilm activity, TIAB has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling.\n\nDifferent clinical trials have reported a cicatrizing and re-epithelializing action of TIAB administered vaginally in the context of cervical conization for pathology related to HPV. Without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients.\n\nOn the basis of the available evidence, the investigators conduct a randomized controlled clinical trial to determine if TIAB treatment in the formulation of vaginal capsules TIAGIN (TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women underwent laparoscopic total hysterectomy for benign gynecological pathology\n\nExclusion Criteria:\n\n* Women underwent non-laparoscopic total hysterectomy\n* Women underwent laparoscopic total hysterectomy for malignant pathology\n* Patients with diabetes mellitus in insulin therapy\n* Smoking patients\n* Patients suffering from chronic rheumatic diseases or chronic diseases not in adequate control.'}, 'identificationModule': {'nctId': 'NCT03791294', 'acronym': 'ISTIAB-0', 'briefTitle': 'Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy ( ISTIAB-0)', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Trial on the Use of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions (TIAB) in the Formulation of Vaginal Capsules in the Prevention of Complications After Total Hysterectomy', 'orgStudyIdInfo': {'id': 'ISTIAB-0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIAB treatment', 'description': 'From the first postoperative day for ten days, single vaginal capsule per day of TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, and Aloe Barbadensis Extract vaginal capsule.', 'interventionNames': ['Drug: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No treatment'}], 'interventions': [{'name': 'TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions', 'type': 'DRUG', 'otherNames': ['TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract'], 'description': 'TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract', 'armGroupLabels': ['TIAB treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Simone Garzon, M.D.', 'role': 'CONTACT', 'email': 'sgarzon@studenti.uninsubria.it', 'phone': '+39 347 0782287'}, {'name': 'Antonio Simone Laganà, M.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@asst-settelaghi.it', 'phone': '+39 329 6279579'}], 'overallOfficials': [{'name': 'Simone Garzon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Antonio Simone Laganà, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Fabio Ghezzi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Jvan Casarin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Simone Garzon', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}