Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy ( ISTIAB-0) (ISTIAB-0)

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

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, 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.

Study Overview

• Status: Unknown
• Conditions: Bleeding; Infection; Complication, Postoperative
• Intervention / Treatment: Drug: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Simone Garzon, M.D.; Phone Number: +39 347 0782287; Email: sgarzon@studenti.uninsubria.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No 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.	Drug: 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; Other Names: TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal bleeding	at least one episode of red vaginal blood loss	At the 30th post operative day
Vaginal vault infection	at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy	At the 30th post operative day
Urinary tract infection	at least one episode of signs and symptoms requiring empiric antibiotic therapy	At the 30th post operative day
Dehiscence of vaginal vault suture	Dehiscence of vaginal vault suture requiring repeat surgery	At the 30th post operative day
Readmission	At least one episode of readmission related to postoperative complications	At the 30th post operative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events due to the use of vaginal capsule therapy: erythema, vaginal and vulvar pruritus, dermatitis.	At the 30th post operative day

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Jvan Casarin, M.D., Università degli Studi dell'Insubria; Principal Investigator: Simone Garzon, M.D., Università degli Studi dell'Insubria; Principal Investigator: Fabio Ghezzi, M.D., Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: December 29, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 29, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Photosensitizing Agents; Dermatologic Agents; Adjuvants, Immunologic; Radiation-Protective Agents; Viscosupplements; Sunscreening Agents; Hyaluronic Acid; Titanium dioxide
• Other Study ID Numbers: ISTIAB-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No