Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

Thyroid Nodule Clinical Trial

Official title:

The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01756534
• Other study ID #: TASMC-ZG-AA-0633-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: December 19, 2012
• Last updated: December 26, 2012
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients who required a thyroidectomy

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter
• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• SURGICEL
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.

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Cotulbea 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. Romanian. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hospitalization time		1 WEEK	No
Primary	The primary endpoint of the study was the postoperative volume of wound drainage		1 WEEK	No
Secondary	The secondary endpoints were events of bleeding requiring wound exploration under anesthesia		48 HOURS	No
Secondary	duration of drain use		1 WEEK	No