A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01226914
• Collaborator: Ethicon, Inc. (Industry)
• Enrollment: 55
• Arms: 2
• Duration (Months): 49

Study Details

Study Description

Brief Summary

Primary Objectives

• To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).

• To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives

• To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.

• To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).

• To compare the length of hospital stay between the two groups of patients.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasm; Goiter	Drug: EVICEL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective randomized placebo-controlled double-blind trial.prospective randomized placebo-controlled double-blind trial.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.	Drug: EVICEL; EVICEL
Experimental: Evicel For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.	Drug: EVICEL; EVICEL

Outcome Measures

Primary Outcome Measures

1. To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B). [90 days]

   First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.

• Patients must have an ECOG performance status of 0-2

• Laboratory values must be within the following ranges:

• Platelet count > 100 k/mm3

• Hemoglobin > 10.0 g/dL

• WBCs > 3.0 k/mm3

• Total bilirubin < 2.6

• Serum Creatinine < 2.0

• PTT and PT/INR within institutional normal limits

• Patients must sign informed consent for study participation

Exclusion Criteria

• Evidence of distant metastasis of thyroid carcinoma

• Recurrent thyroid cancer

• Prior thyroid surgery or surgery to the neck.

• Patients with diagnosed coagulation disorders

• Prior irradiation to the neck area

• Prior chemotherapy for the current diagnosis

• Patients on therapeutic warfarin

• Patients with psychological or cognitive issues that, in the opinion of the investigator, will make them unable to adequately report pain levels

• Patients in an immune deficient state

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical University of South Carolina
• Ethicon, Inc.

Investigators

• Principal Investigator: Joshua Hornig, MD, Medical University of South Carolina
• Study Director: Shaun A Nguyen, M.D.,CPI, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaun A. Nguyen, Associate Professor - Director of Clinical Research, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01226914
• Other Study ID Numbers: EVICEL
• First Posted: Oct 22, 2010
• Last Update Posted: Feb 5, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Shaun A. Nguyen, Associate Professor - Director of Clinical Research, Medical University of South Carolina: EVICEL, Fibrin Sealant, Thyroidectomy
• Additional relevant MeSH terms: Thyroid Neoplasms; Postoperative Complications

Study Results

Participant Flow

Recruitment Details	subjects undergoing total or partial thyroidectomy will be consented for this industry-sponsored prospective randomized placebo-controlled double-blind trial.
Pre-assignment Detail	Subjects will be randomized to placebo or Evicel group based on a computer-generated random number sequence.

Arm/Group Title	EVICEL Group	Placebo Group
Arm/Group Description
Period Title: Overall Study
STARTED	28	27
COMPLETED	28	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	EVICEL Group	Placebo Group	Total
Arm/Group Description	For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.	For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.	Total of all reporting groups
Overall Participants	28	27	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	27 100%	55 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.8 (15.2)	51.9 (11.5)	50.2 (11.2)
Sex: Female, Male (Count of Participants)
Female	24 85.7%	24 88.9%	48 87.3%
Male	4 14.3%	3 11.1%	7 12.7%

Outcome Measures

1. Primary Outcome

Title	To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).
Description	First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EVICEL Group	Placebo Group
Arm/Group Description	For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.	For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
Measure Participants	28	27
Median (Inter-Quartile Range) [mL]	96.3	120

Adverse Events

Time Frame	Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
Arm/Group Title	EVICEL		Placebo
Arm/Group Description	For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.		For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
All Cause Mortality
	EVICEL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/27 (0%)
Serious Adverse Events
	EVICEL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	EVICEL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/28 (32.1%)		3/27 (11.1%)
Endocrine disorders
hypocalcemia	1/28 (3.6%)	1	2/27 (7.4%)	2
hypocalcemia tetany	2/28 (7.1%)	2	0/27 (0%)	0
Injury, poisoning and procedural complications
TVC paralysis	3/28 (10.7%)	3	1/27 (3.7%)	1
Laryngeal edema	1/28 (3.6%)	1	0/27 (0%)	0
asymptomatic hematoma	1/28 (3.6%)	1	0/27 (0%)	0
Non-admit ED Incisional and Facial Swelling	1/28 (3.6%)	1	0/27 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.