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The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

18 Years
Open (Enrolling)
Thyroid Nodule, Thyroid Diseases, Goiter

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Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel-Aviv Sourasky Medical Center


Israel: Ministry of Health

Study ID:




Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Thyroid Nodule
  • Thyroid Diseases
  • Goiter
  • Goiter
  • Thyroid Diseases
  • Thyroid Nodule