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

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

Study Overview

• Status: Unknown
• Conditions: Thyroid Diseases; Goiter; Thyroid Nodule
• Intervention / Treatment: Device: SURGICEL

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 66234
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: CONVENTIONAL HEMOSTASIS; patients for whom conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) were used to achieve hemostasis
ACTIVE_COMPARATOR: SURGICEL; patients will receive an oxidized cellulose patch (Surgicel®) in addition to conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint of the study was the postoperative volume of wound drainage	1 WEEK

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary endpoints were events of bleeding requiring wound exploration under anesthesia	48 HOURS
duration of drain use	1 WEEK

Other Outcome Measures

Outcome Measure	Time Frame
hospitalization time	1 WEEK

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: ZIV GIL, MD PhD, Tel-Aviv Sourasky Medical Center

Publications and helpful links

General 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.
• 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. No abstract available. Romanian.
• Amit 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): March 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 26, 2012
• First Posted (ESTIMATE): December 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 27, 2012
• Last Update Submitted That Met QC Criteria: December 26, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: TASMC-ZG-AA-0633-CTIL