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Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy

NCT ID: NCT03789799

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infection Bleeding Complication, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled double-blind trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions

Intervention Type OTHER

TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract

Placebo

From the first postoperative day for ten days, single vaginal capsule per day of sodium Hyaluronate, and Aloe Barbadensis Extract vaginal capsule.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract

Interventions

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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

Intervention Type OTHER

Placebo

Placebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Simone Garzon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Garzon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Antonio Simone Laganà, M.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Fabio Ghezzi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Jvan Casarin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Central Contacts

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Simone Garzon, M.D.

Role: CONTACT

Phone: +39 347 0782287

Email: [email protected]

Antonio Simone Laganà, M.D.

Role: CONTACT

Phone: ‭+39 329 6279579‬

Email: [email protected]

Other Identifiers

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ISTIAB-1

Identifier Type: -

Identifier Source: org_study_id