Clinical trial NCT03789799: Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infection
Bleeding
Complication, Postoperative
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double-blind trial
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Vaginal bleeding
timeFrame: Between the 10th post operative day and the 30th post operative day
measure: Vaginal vault infection
timeFrame: Between the first post operative day and the 30th post operative day
measure: Urinary tract infection
timeFrame: Between the 10th post operative day and the 30th post operative day
measure: Dehiscence of vaginal vault suture
timeFrame: Between the 10th post operative day and the 30th post operative day
measure: Readmission
timeFrame: Between the day of discharge and the 30th post operative day
Secondary outcomes:
measure: Adverse events
timeFrame: Between the first post operative day and the 30th post operative day
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
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
References: