Bleeding, Complication, Postoperative, Infection
Conditions
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.
Interventions
TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract
OTHERPlacebo
Placebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract
Sponsors
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled double-blind trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal bleeding | Between the 10th post operative day and the 30th post operative day | at least one episode of red vaginal blood loss |
| Vaginal vault infection | Between the first post operative day and the 30th post operative day | at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy |
| Urinary tract infection | Between the 10th post operative day and the 30th post operative day | at least one episode of signs and symptoms requiring empiric antibiotic therapy |
| Dehiscence of vaginal vault suture | Between the 10th post operative day and the 30th post operative day | Dehiscence of vaginal vault suture requiring repeat surgery |
| Readmission | Between the day of discharge and the 30th post operative day | At least one episode of readmission related to postoperative complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Between the first post operative day and the 30th post operative day | Adverse events due to the use of vaginal capsule therapy: erythema, vaginal and vulvar pruritus, dermatitis. |
Contacts
Primary ContactSimone Garzon, M.D.
Backup ContactAntonio Simone Laganà, M.D.
Outcome results
None listed