GoiterNCT05103956
Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Postoperative of the Thyroidectomy.
An observational study of Goiter, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
Observational study with non-inferiority, prospective, randomized (1: 1) and open-label medical device. The study has 2 treatment groups (HEMOPATCH® versus standard hemostasis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Goiter
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 1 Apr 2022
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The present study includes older patients who underwent total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital. They must sign an informed consent and know the study procedures that are detailed in the protocol.
Who may be able to join
- Patients of legal age.
- Indication of total thyroidectomy due to multinodular goiter.
- Accept to enter the study and sign the informed consent.
- Patient willing and able to complete clinical trial procedures, as described described in the protocol.
Who cannot join
- Patients under 18 years of age.
- Patients with surgical indication for hemithyroidectomy or subtotal thyroidectomy (eg unilateral nodular goiters).
- Multinodular goiter with high suspicion or preoperative diagnosis of cancer (Bethesda V and VI and / or infiltration of neighboring structures on imaging tests).
- Known allergy or hypersensitivity to a component of the Hemopatch® investigational treatments, riboflavin, or bovine proteins.
- Concurrent or prior therapy with systemic pharmacological agents that promote blood clotting, including, but not limited to, tranexamic acid, activated factor VII, fibrinogen, and aprotinin.
- Pregnancy or breastfeeding.
Show all 12Show fewer
- Refuse to enter the study and sign the informed consent.
- Not agreeing to carry out all the planned follow-up.
- Concurrent participation in another clinical trial with a medical device or drug or with interfering endpoints Inability to understand the nature and scope of the trial and the required procedures.
- Criteria to be verified during surgery (Intraoperative exclusion criteria):
- Persistent major bleeding after primary hemostasis.
- Infection of the surgical area.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Juan Manuel Martos Martinez, 955 01 20 00, jmmartos66@gmail.com
Carlos García Pérez, 955 04 31 27, administracion.eecc.hvm.sspa@juntadeandalucia.es
About this study
Official title: Regular Treatment Versus Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Immediate Postoperative of the Thyroidectomy, Unicentric Study, Non-inferiority, Open and Randomized (Tiropatch Study)
Observational study with non-inferiority, prospective, randomized (1: 1) and open-label medical device. The study has 2 treatment groups (HEMOPATCH® versus standard hemostasis).
Read the detailed description
The main objective is to determine if there is a reduction in the volume of exudate in the surgical bed with the application of the collagen and polyethylene glycol hemostatic agent.
The present study includes patients undergoing total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital.
The estimated sample calculation of patients enrolled in the study is 108 (2 groups, 1:1 ratio).
The patients don´t know what type of hemostatic the patients are going to receive (single blind).
The duration of patient follow-up will be 30 +/- 10 days after surgery.
- Conditions
- Goiter
- Medical subject headings
- Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Study Group) | HEMOPATCH® (Sealing / hemostatic patch of collagen and e polyethylene glycol) | |
| Group B (Control Group) | No hemostatic or the standard (ligatures and oxidized cellulose regenerated). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of changes in the exudate volume of the surgical bed with the application of the hemostatic agent of collagen and polyethylene glycol.
Fixed periods of time will be established to evaluate the exudate from the surgical bed.
It will be evaluated 18 hours after surgery by cervical ultrasound.
Measured: Up to 18 hours.
Secondary outcomes (4)
Rate of changes in the patient's symptoms in the postoperative period of thyroidectomy after the application of the hemostatic agent of collagen and polyethylene glycol.
Decrease in the number of dyspnea at 24 hours and 30 days postoperatively.
Measured: Up to 4 weeks.
Improvement in patient satisfaction after the application of the collagen and polyethylene glycol hemostatic agent, in relation to the surgical experience in the postoperative period of thyroidectomy.
Satisfaction survey at discharge and 30 days after the intervention.
Measured: Up to 4 weeks.
Rate of improvement in postoperative complications of thyroidectomy after the application of the collagen and polyethylene glycol hemostatic agent.
Performance of the Trousseau test every 8 hours from surgery to hospital discharge and Calcemia (mg/dl) at discharge and at check-up in consultations (30 days) with total proteins.
Measured: Up to 4 weeks.
Incidence rate of adverse effects after the use of the collagen and polyethylene glycol hemostatic agent in thyroid surgery.
Number of adverse events that have occurred in study patients.
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoiterStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Manuel Martos Martínez, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103956
- Sponsor's protocol ID
- TIROPATCH
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Treatment Versus Hemostatic Patch/Collagen Sealant and Polyethylene Glycol (Hemopatch) in the Immediate Postoperative of the Thyroidectomy, Unicentric Study, Non-inferiority, Open and Randomized (Tiropatch Study)
- ClinicalTrials.gov ID
- NCT05103956
- Acronym / sponsor ID
- TIROPATCH
- Conditions
- Goiter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 2 Nov 2021 (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.
Observational study with non-inferiority, prospective, randomized (1: 1) and open-label medical device. The study has 2 treatment groups (HEMOPATCH® versus standard hemostasis).
Detailed description
The main objective is to determine if there is a reduction in the volume of exudate in the surgical bed with the application of the collagen and polyethylene glycol hemostatic agent.
The present study includes patients undergoing total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital.
The estimated sample calculation of patients enrolled in the study is 108 (2 groups, 1:1 ratio).
The patients don´t know what type of hemostatic the patients are going to receive (single blind).
The duration of patient follow-up will be 30 +/- 10 days after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Study Group) | – | –HEMOPATCH® (Sealing / hemostatic patch of collagen and e polyethylene glycol) |
| Group B (Control Group) | – | –No hemostatic or the standard (ligatures and oxidized cellulose regenerated). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study includes older patients who underwent total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital. They must sign an informed consent and know the study procedures that are detailed in the protocol.
Key inclusion criteria (4 listed)
- Patients of legal age.
- Indication of total thyroidectomy due to multinodular goiter.
- Accept to enter the study and sign the informed consent.
- Patient willing and able to complete clinical trial procedures, as described described in the protocol.
Key exclusion criteria (12 listed)
- Patients under 18 years of age.
- Patients with surgical indication for hemithyroidectomy or subtotal thyroidectomy (eg unilateral nodular goiters).
- Multinodular goiter with high suspicion or preoperative diagnosis of cancer (Bethesda V and VI and / or infiltration of neighboring structures on imaging tests).
- Known allergy or hypersensitivity to a component of the Hemopatch® investigational treatments, riboflavin, or bovine proteins.
- Concurrent or prior therapy with systemic pharmacological agents that promote blood clotting, including, but not limited to, tranexamic acid, activated factor VII, fibrinogen, and aprotinin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of changes in the exudate volume of the surgical bed with the application of the hemostatic agent of collagen and polyethylene glycol.
Time frame: Up to 18 hours.
Fixed periods of time will be established to evaluate the exudate from the surgical bed. It will be evaluated 18 hours after surgery by cervical ultrasound.
4 secondary outcomes
Rate of changes in the patient's symptoms in the postoperative period of thyroidectomy after the application of the hemostatic agent of collagen and polyethylene glycol.
Time frame: Up to 4 weeks.
Improvement in patient satisfaction after the application of the collagen and polyethylene glycol hemostatic agent, in relation to the surgical experience in the postoperative period of thyroidectomy.
Time frame: Up to 4 weeks.
Rate of improvement in postoperative complications of thyroidectomy after the application of the collagen and polyethylene glycol hemostatic agent.
Time frame: Up to 4 weeks.
Incidence rate of adverse effects after the use of the collagen and polyethylene glycol hemostatic agent in thyroid surgery.
Time frame: Up to 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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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.
Juan Manuel Martos Martínez principal investigator
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Goiter, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 4 inclusion and 12 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 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Juan Manuel Martos Martínez (955 01 20 00, jmmartos66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of changes in the exudate volume of the surgical bed with the application of the hemostatic agent of collagen and polyethylene glycol. (time frame: Up to 18 hours.). 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 17 Nov 2021.