Thyroid NoduleNCT01756534
Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
A study testing SURGICEL in people with Thyroid Nodule and Thyroid Diseases, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This single-blind prospective randomized study was designed to assess the efficacy and safety of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Diseases, Goiter
- What is being tested?
- SURGICEL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- 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
Who may be able to join
- All patients who required a thyroidectomy
Who cannot join
- Unwilling or unable to consent
- Age < 18 years
- known allergy to oxidized cellulose
- Inability to discontinue use of anticoagulants 10 days before surgery
- Coagulopathy that could not be corrected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
This single-blind prospective randomized study was designed to assess the efficacy and safety of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery
Read the detailed description
patients who require a thyroidectomy will be enrolled after informed consent will begiven. Prior to thyroidectomy, patients will be randomized to two groups: 1) use of conventional surgical procedures to achieve hemostasis,i.e., ligatures and bipolar electrocauterization alone, and 2) use of oxidized cellulose patch (Surgicel©) in addition to classical methods (ligature; bipolar electrocautery). All anticoagulants will be discontinued 10 days prior to the operation, if this will not be possible the patient will be excluded. The investigators will perform the specified procedure in accordance with accepted clinical practice standards. At the end of the thyroidectomy, a meticulous hemostasis will be achieved. Before wound closure, the sealed affiliation envelopes will be opened and 1-2×2 cm oxidized cellulose patch will be placed over the thyroid bed depending on patient randomization. Next, a suction drain will be placed. The drains will be removed when the secretion volume/day will be less than 20 cc.
All operations will be performed under general anesthesia by three head and neck surgeons who had experience in thyroid surgery. Outcome measures will include duration of operation, hemodynamic variables on emergence (blood pressure and heart rate), volume of secretion in the drain, time to removal of wound drain, length of postoperative hospital stay, and incidence of postoperative complications, i.e. hemorrhage, transient hypoparathyroidism, wound infection, seroma, and recurrent laryngeal nerve palsy. Evaluation of the postoperative course and recording of data will be done by one surgeons blinded to the intervention (MA). Follow-up for this study will be ended one month after the surgery.
- Conditions
- Thyroid Nodule, Thyroid Diseases, Goiter
- Being tested
- SURGICEL
- Medical subject headings
- Thyroid Nodule, Thyroid Diseases, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGICELDevice
Surgicel® (Johnson and Johnson, New Brunswick, NJ, USA), an oxidized cellulose hemostatic agent, is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical.
| Study group | Role | What they receive |
|---|---|---|
| CONVENTIONAL HEMOSTASIS | No intervention | patients for whom conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) were used to achieve hemostasis |
| SURGICEL | Active comparator | patients will receive an oxidized cellulose patch (Surgicel®) in addition to conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) Receives: Device: SURGICEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study was the postoperative volume of wound drainage
Measured: 1 WEEK
Secondary outcomes (2)
The secondary endpoints were events of bleeding requiring wound exploration under anesthesia
Measured: 48 HOURS
duration of drain use
Measured: 1 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ZIV GIL, MD PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756534
- Sponsor's protocol ID
- TASMC-ZG-AA-0633-CTIL
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quick MW, Naeve J, Davidson N, Lester HA. Incubation with horse serum increases viability and decreases background neurotransmitter uptake in Xenopus oocytes. Biotechniques. 1992 Sep;13(3):357-61. No abstract available.
PubMed 1356369Cotulbea S, Marin I, Golumba R, Barbos R, Epure V, Valean M, Anghel I. [Our clinical management in treating seromucous otitis]. Rev Chir Oncol Radiol O R L Oftalmol Stomatol Otorinolaringol. 1988 Oct-Dec;33(4):259-64. No abstract available. Romanian.
PubMed 2978438Amit M, Binenbaum Y, Cohen JT, Gil Z. Effectiveness of an oxidized cellulose patch hemostatic agent in thyroid surgery: a prospective, randomized, controlled study. J Am Coll Surg. 2013 Aug;217(2):221-5. doi: 10.1016/j.jamcollsurg.2013.03.022.
PubMed 23870217
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01756534
- Acronym / sponsor ID
- TASMC-ZG-AA-0633-CTIL
- Conditions
- Thyroid Nodule, Thyroid Diseases, Goiter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Dec 2012 (estimated)
- 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.
This single-blind prospective randomized study was designed to assess the efficacy and safety of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery
Detailed description
patients who require a thyroidectomy will be enrolled after informed consent will begiven. Prior to thyroidectomy, patients will be randomized to two groups: 1) use of conventional surgical procedures to achieve hemostasis,i.e., ligatures and bipolar electrocauterization alone, and 2) use of oxidized cellulose patch (Surgicel©) in addition to classical methods (ligature; bipolar electrocautery). All anticoagulants will be discontinued 10 days prior to the operation, if this will not be possible the patient will be excluded. The investigators will perform the specified procedure in accordance with accepted clinical practice standards. At the end of the thyroidectomy, a meticulous hemostasis will be achieved. Before wound closure, the sealed affiliation envelopes will be opened and 1-2×2 cm oxidized cellulose patch will be placed over the thyroid bed depending on patient randomization. Next, a suction drain will be placed. The drains will be removed when the secretion volume/day will be less than 20 cc.
All operations will be performed under general anesthesia by three head and neck surgeons who had experience in thyroid surgery. Outcome measures will include duration of operation, hemodynamic variables on emergence (blood pressure and heart rate), volume of secretion in the drain, time to removal of wound drain, length of postoperative hospital stay, and incidence of postoperative complications, i.e. hemorrhage, transient hypoparathyroidism, wound infection, seroma, and recurrent laryngeal nerve palsy. Evaluation of the postoperative course and recording of data will be done by one surgeons blinded to the intervention (MA). Follow-up for this study will be ended one month after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONVENTIONAL HEMOSTASIS | No intervention | –patients for whom conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) were used to achieve hemostasis |
| SURGICEL | Active comparator | Device: SURGICELpatients will receive an oxidized cellulose patch (Surgicel®) in addition to conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who required a thyroidectomy
Key exclusion criteria (5 listed)
- Unwilling or unable to consent
- Age < 18 years
- known allergy to oxidized cellulose
- Inability to discontinue use of anticoagulants 10 days before surgery
- Coagulopathy that could not be corrected
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 |
|---|---|---|
| SURGICELSurgicel® (Johnson and Johnson, New Brunswick, NJ, USA), an oxidized cellulose hemostatic agent, is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. | Device | SURGICEL |
Primary outcome
The primary endpoint of the study was the postoperative volume of wound drainage
Time frame: 1 WEEK
2 secondary outcomes
The secondary endpoints were events of bleeding requiring wound exploration under anesthesia
Time frame: 48 HOURS
duration of drain use
Time frame: 1 WEEK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
- Background: PubMed 1356369Quick MW, Naeve J, Davidson N, Lester HA. Incubation with horse serum increases viability and decreases background neurotransmitter uptake in Xenopus oocytes. Biotechniques. 1992 Sep;13(3):357-61. No abstract available.
- Background: PubMed 2978438Cotulbea S, Marin I, Golumba R, Barbos R, Epure V, Valean M, Anghel I. [Our clinical management in treating seromucous otitis]. Rev Chir Oncol Radiol O R L Oftalmol Stomatol Otorinolaringol. 1988 Oct-Dec;33(4):259-64. No abstract available. Romanian.
- Derived from this study: PubMed 23870217Amit M, Binenbaum Y, Cohen JT, Gil Z. Effectiveness of an oxidized cellulose patch hemostatic agent in thyroid surgery: a prospective, randomized, controlled study. J Am Coll Surg. 2013 Aug;217(2):221-5. doi: 10.1016/j.jamcollsurg.2013.03.022.
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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.
ZIV GIL, MD PhD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURGICEL in people with Thyroid Nodule and Thyroid Diseases, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 27 Dec 2012. 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 Israel. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study was the postoperative volume of wound drainage (time frame: 1 WEEK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756534, which also lists 3 linked publications.
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 27 Dec 2012.