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

NCT ID: NCT01756534

Last Updated: 2012-12-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

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

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.

Conditions

Thyroid Nodule; Thyroid Diseases; Goiter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CONVENTIONAL HEMOSTASIS

patients for whom conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) were used to achieve hemostasis

Group Type: NO_INTERVENTION

No interventions assigned to this group

SURGICEL

patients will receive an oxidized cellulose patch (Surgicel®) in addition to conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone)

Group Type: ACTIVE_COMPARATOR

SURGICEL

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ZIV GIL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 1356369 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2978438 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23870217 (View on PubMed)

Other Identifiers

TASMC-ZG-AA-0633-CTIL

Identifier Type: -

Identifier Source: org_study_id