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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756534
Recruitment Status : Unknown
Verified December 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 27, 2012
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Thyroid Nodule Thyroid Diseases Goiter Device: SURGICEL Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
Study Start Date : January 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
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)
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.

Primary Outcome Measures :
  1. The primary endpoint of the study was the postoperative volume of wound drainage [ Time Frame: 1 WEEK ]

Secondary Outcome Measures :
  1. The secondary endpoints were events of bleeding requiring wound exploration under anesthesia [ Time Frame: 48 HOURS ]
  2. duration of drain use [ Time Frame: 1 WEEK ]

Other Outcome Measures:
  1. hospitalization time [ Time Frame: 1 WEEK ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756534

Tel Aviv Medical Center
Tel Aviv, Israel, 66234
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: ZIV GIL, MD PhD Tel-Aviv Sourasky Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01756534     History of Changes
Other Study ID Numbers: TASMC-ZG-AA-0633-CTIL
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Cellulose, Oxidized