The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary endpoint of the study was the postoperative volume of wound drainage
ZIV GIL, MD PhD
Tel-Aviv Sourasky Medical Center
Israel: Ministry of Health