InfectionPhase 3ISTIAB-1NCT03789799
Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy
A Phase 3 study testing TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions in people with Infection and Bleeding, run by Università degli Studi dell'Insubria.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection, Bleeding, Complication, Postoperative
- What is being tested?
- TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women underwent laparoscopic total hysterectomy for benign gynecological pathology
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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.
- Conditions
- Infection, Bleeding, Complication, Postoperative
- Being tested
- TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions, Placebo
- Medical subject headings
- Infections, Hemorrhage, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ionsOther
TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract
PlaceboOther
Placebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract
| Study group | Role | What they receive |
|---|---|---|
| TIAB treatment | Experimental | 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. Receives: Other: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions |
| Placebo | Placebo comparator | From the first postoperative day for ten days, single vaginal capsule per day of sodium Hyaluronate, and Aloe Barbadensis Extract vaginal capsule. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal bleeding
at least one episode of red vaginal blood loss
Measured: Between the 10th post operative day and the 30th post operative day
Vaginal vault infection
at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy
Measured: Between the first post operative day and the 30th post operative day
Urinary tract infection
at least one episode of signs and symptoms requiring empiric antibiotic therapy
Measured: Between the 10th post operative day and the 30th post operative day
Dehiscence of vaginal vault suture
Dehiscence of vaginal vault suture requiring repeat surgery
Measured: Between the 10th post operative day and the 30th post operative day
Readmission
At least one episode of readmission related to postoperative complications
Measured: Between the day of discharge and the 30th post operative day
Secondary outcomes (1)
Adverse events
Adverse events due to the use of vaginal capsule therapy: erythema, vaginal and vulvar pruritus, dermatitis.
Measured: Between the first post operative day and the 30th post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled double-blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Garzon, Università degli Studi dell'Insubria
- Investigators
- Simone Garzon, M.D., Principal investigator, Università degli Studi dell'InsubriaAntonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'InsubriaFabio Ghezzi, M.D., Principal investigator, Università degli Studi dell'InsubriaJvan Casarin, M.D., Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789799
- Sponsor's protocol ID
- ISTIAB-1
- Acronym
- ISTIAB-1
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03789799
- Acronym / sponsor ID
- ISTIAB-1 / ISTIAB-1
- Conditions
- Infection, Bleeding, Complication, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled double-blind trial
| Arm | Type | Receives |
|---|---|---|
| TIAB treatment | Experimental | Other: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ionsFrom 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. |
| Placebo | Placebo comparator | Other: PlaceboFrom the first postoperative day for ten days, single vaginal capsule per day of sodium Hyaluronate, and Aloe Barbadensis Extract vaginal capsule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women underwent laparoscopic total hysterectomy for benign gynecological pathology
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ionsTIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract | Other | TIAB treatment |
| PlaceboPlacebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract | Other | Placebo |
Primary outcome
Vaginal bleeding
Time frame: Between the 10th post operative day and the 30th post operative day
at least one episode of red vaginal blood loss
Vaginal vault infection
Time frame: 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
Time frame: 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
Time frame: Between the 10th post operative day and the 30th post operative day
Dehiscence of vaginal vault suture requiring repeat surgery
Readmission
Time frame: Between the day of discharge and the 30th post operative day
At least one episode of readmission related to postoperative complications
1 secondary outcome
Adverse events
Time frame: Between the first post operative day and the 30th post operative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Garzon, M.D. principal investigator
Università degli Studi dell'Insubria
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
Fabio Ghezzi, M.D. principal investigator
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions in people with Infection and Bleeding, run by Università degli Studi dell'Insubria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Garzon, M.D. (+39 347 0782287, sgarzon@studenti.uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal bleeding (time frame: Between the 10th post operative day and the 30th post operative day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.