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Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy (ISTIAB-1)

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ClinicalTrials.gov Identifier: NCT03789799
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Simone Garzon, Università degli Studi dell'Insubria

Brief Summary:

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.

The 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.

Different 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.

On the basis of the available evidence, we 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.


Condition or disease Intervention/treatment Phase
Infection Bleeding Complication, Postoperative Other: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled double-blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: TIAGIN and placebo will be provided in identical non-distinguishable packaging and formulations. To each pack a unique random ID will be assigned based on an independently generated random scheme (www.randomization.com). Patients will blindly receive consecutively a single pack of 10 vaginal capsules. The same blinding procedure will also be present for health professionals (double-blind study) as only the manufacturer will be aware of the contents of the pack. For each enrolled patient, the patient ID will be associated to the packaging ID, the maintenance of the confidentiality of such data will be the responsibility of the Principal Investigator, to which the contents of the pack will be revealed only at the end of the study for the final data analysis.
Primary Purpose: Treatment
Official Title: Randomized Controlled 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: TIAB treatment
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.
Other: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions
TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract

Placebo Comparator: Placebo
From the first postoperative day for ten days, single vaginal capsule per day of sodium Hyaluronate, and Aloe Barbadensis Extract vaginal capsule.
Other: Placebo
Placebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract




Primary Outcome Measures :
  1. Vaginal bleeding [ Time Frame: Between the 10th post operative day and the 30th post operative day ]
    at least one episode of red vaginal blood loss

  2. Vaginal vault infection [ Time Frame: Between the first post operative day and the 30th post operative day ]
    at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy

  3. Urinary tract infection [ Time Frame: Between the 10th post operative day and the 30th post operative day ]
    at least one episode of signs and symptoms requiring empiric antibiotic therapy

  4. Dehiscence of vaginal vault suture [ Time Frame: Between the 10th post operative day and the 30th post operative day ]
    Dehiscence of vaginal vault suture requiring repeat surgery

  5. Readmission [ Time Frame: Between the day of discharge and the 30th post operative day ]
    At least one episode of readmission related to postoperative complications


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Between the first post operative day and the 30th post operative day ]
    Adverse events due to the use of vaginal capsule therapy: erythema, vaginal and vulvar pruritus, dermatitis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women underwent laparoscopic total hysterectomy for benign gynecological pathology

Exclusion Criteria:

  • Women underwent non-laparoscopic total hysterectomy
  • Women underwent laparoscopic total hysterectomy for malignant pathology
  • Patients with diabetes mellitus in insulin therapy
  • Smoking patients
  • Patients suffering from chronic rheumatic diseases or chronic diseases not in adequate control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789799


Contacts
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Contact: Simone Garzon, M.D. +39 347 0782287 sgarzon@studenti.uninsubria.it
Contact: Antonio Simone Laganà, M.D. ‭+39 329 6279579‬ antoniosimone.lagana@asst-settelaghi.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Simone Garzon, M.D. Università degli Studi dell'Insubria
Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria
Principal Investigator: Fabio Ghezzi, M.D. Università degli Studi dell'Insubria
Principal Investigator: Jvan Casarin, M.D. Università degli Studi dell'Insubria

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Responsible Party: Simone Garzon, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03789799     History of Changes
Other Study ID Numbers: ISTIAB-1
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Titanium dioxide
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Sunscreening Agents
Radiation-Protective Agents
Dermatologic Agents
Photosensitizing Agents