Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study
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|ClinicalTrials.gov Identifier: NCT01756534|
Recruitment Status : Unknown
Verified December 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Active, not recruiting
First Posted : December 27, 2012
Last Update Posted : December 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodule Thyroid Diseases Goiter||Device: SURGICEL||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||December 2013|
No Intervention: CONVENTIONAL HEMOSTASIS
patients for whom conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) were used to achieve hemostasis
Active Comparator: SURGICEL
patients will receive an oxidized cellulose patch (Surgicel®) in addition to conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone)
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.
- The primary endpoint of the study was the postoperative volume of wound drainage [ Time Frame: 1 WEEK ]
- The secondary endpoints were events of bleeding requiring wound exploration under anesthesia [ Time Frame: 48 HOURS ]
- duration of drain use [ Time Frame: 1 WEEK ]
- hospitalization time [ Time Frame: 1 WEEK ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756534
|Tel Aviv Medical Center|
|Tel Aviv, Israel, 66234|
|Principal Investigator:||ZIV GIL, MD PhD||Tel-Aviv Sourasky Medical Center|