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

Not Applicable

• Conditions: Thyroid Nodule; Thyroid Diseases; Goiter
• Interventions: Device: SURGICEL

• Registration Number: NCT01756534
• Lead Sponsor: 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

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 Timeline

• Study Start: 2011-01
• Status Verified: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-26
• Last Update Submitted: 2012-12-26
• Study First Posted: 2012-12-27
• Last Update Posted: 2012-12-27
• Primary Completion: 2013-03
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study was the postoperative volume of wound drainage	1 WEEK

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel