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

NCT01756534 | Unknown DMC

• 1 other identifier: TASMC-ZG-AA-0633-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroid Nodule; Thyroid Diseases; Goiter

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study was the postoperative volume of wound drainage

  1 WEEK

Secondary Outcomes (2)

• The secondary endpoints were events of bleeding requiring wound exploration under anesthesia

  48 HOURS

• duration of drain use

  1 WEEK

Other Outcomes (1)

• hospitalization time

  1 WEEK

Study Arms (2)

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)

Device: SURGICEL

Interventions

SURGICEL DEVICE

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.

SURGICEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who required a thyroidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 66234, Israel

Location

Related Publications (3)

• 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.

  PMID: 1356369 BACKGROUND

• 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.

  PMID: 2978438 BACKGROUND

• 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.

  PMID: 23870217 DERIVED

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Diseases; Goiter

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Study Officials

• ZIV GIL, MD PhD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 27, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

IL (1)