Study to Evaluate Safety & Effectiveness of Spinal Sealant

This study has been completed.

Sponsor:

Collaborator:

Covidien

Information provided by (Responsible Party):

Covidien ( Confluent Surgical )

ClinicalTrials.gov Identifier:

NCT00444067

First received: March 6, 2007

Last updated: July 17, 2012

Last verified: July 2012

History of Changes

Results First Received: July 17, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Cerebrospinal Fluid Leakage, Subdural
Interventions:	Device: Spinal Sealant Other: Standard of Care

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was consented on May 15, 2007. The last subject visit occurred on August 12, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Washout study, no run-in or wash-out periods.

Reporting Groups

	Description
Spinal Sealant	DuraSeal Spinal Sealant System
Control	Standard of care methods used as an adjunct to sutured dural repair.

Participant Flow: Overall Study

	Spinal Sealant	Control
STARTED	74	24
COMPLETED	74	23
NOT COMPLETED	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
Spinal Sealant	DuraSeal Spinal Sealant System
Control	Standard of care methods used as an adjunct to sutured dural repair.
Total	Total of all reporting groups

Baseline Measures

	Spinal Sealant	Control	Total
Number of Participants [units: participants]	74	24	98
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	69	23	92
>=65 years	5	1	6
Gender [units: participants]
Female	30	9	39
Male	44	15	59
Region of Enrollment [units: participants]
United States	74	24	98
Age (Statistics) [units: years] Mean ± Standard Deviation	44.25 ± 13.06	44.70 ± 11.44	44.36 ± 12.62

Outcome Measures

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1. Primary:

Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) [ Time Frame: Intra-operative ]

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2. Other Pre-specified:

Incidence of Post-Operative CSF Leaks [ Time Frame: 90 Days ]

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3. Other Pre-specified:

Incidence of Post-Operative Surgical Site Infections (SSIs) [ Time Frame: 90 Days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor can review results at least 30 days prior to public release, and at the request of Sponsor, the PI will withhold submission for an additional period, not to exceed 30 days. The first publication of the study results shall be made in conjunction with a joint, multi-center publication of the results. If a multi-center publication is not submitted within 12 months after the conclusion of the study, the PI may publish the results from their individual site.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Tracy Jennings, CCRA/Clinical Project Manager
Organization: Confluent Surgical Inc., dba Covidien
phone: 781-839-1735
e-mail: tracy.jennings@covidien.com

No publications provided

Responsible Party:	Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:	NCT00444067 History of Changes
Other Study ID Numbers:	DS3-06-002
Study First Received:	March 6, 2007
Results First Received:	July 17, 2012
Last Updated:	July 17, 2012
Health Authority:	United States: Food and Drug Administration

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