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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Thyroid Diseases; Thyroid Nodule; Goiter

Treatments: Device: SURGICEL

Study type: Interventional

Funder types: Other

Identifiers

NCT01756534

TASMC-ZG-AA-0633-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

CONVENTIONAL HEMOSTASIS

No Intervention group

Description:

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

SURGICEL

Active Comparator group

Description:

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

Treatment:

Device: SURGICEL