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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01756534
First received: December 19, 2012
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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 Intervention
Thyroid Nodule
Thyroid Diseases
Goiter
Device: SURGICEL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • The primary endpoint of the study was the postoperative volume of wound drainage [ Time Frame: 1 WEEK ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoints were events of bleeding requiring wound exploration under anesthesia [ Time Frame: 48 HOURS ] [ Designated as safety issue: No ]
  • duration of drain use [ Time Frame: 1 WEEK ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • hospitalization time [ Time Frame: 1 WEEK ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756534

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01756534     History of Changes
Other Study ID Numbers: TASMC-ZG-AA-0633-CTIL
Study First Received: December 19, 2012
Last Updated: December 26, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Hemostatics
Cellulose, Oxidized
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014