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

Infection Clinical Trial

— ISTIAB-1  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03789799
• Other study ID #: ISTIAB-1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Università degli Studi dell'Insubria
• Contact: Simone Garzon, M.D.
• Phone: +39 347 0782287
• Email: sgarzon[@]studenti.uninsubria.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Complication, Postoperative
• Infection
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal bleeding	at least one episode of red vaginal blood loss	Between the 10th post operative day and the 30th post operative day
Primary	Vaginal vault infection	at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy	Between the first post operative day and the 30th post operative day
Primary	Urinary tract infection	at least one episode of signs and symptoms requiring empiric antibiotic therapy	Between the 10th post operative day and the 30th post operative day
Primary	Dehiscence of vaginal vault suture	Dehiscence of vaginal vault suture requiring repeat surgery	Between the 10th post operative day and the 30th post operative day
Primary	Readmission	At least one episode of readmission related to postoperative complications	Between the day of discharge and the 30th post operative day
Secondary	Adverse events	Adverse events due to the use of vaginal capsule therapy: erythema, vaginal and vulvar pruritus, dermatitis.	Between the first post operative day and the 30th post operative day