Infection Clinical Trial
Official title:
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.
n/a
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