Study to Evaluate Safety & Effectiveness of Spinal Sealant
A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
1 other identifier
interventional
98
1 country
1
Brief Summary
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2007
CompletedFirst Posted
Study publicly available on registry
March 7, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
August 21, 2012
CompletedSeptember 7, 2017
September 1, 2014
2.3 years
March 6, 2007
July 17, 2012
August 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)
Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.
Intra-operative
Other Outcomes (2)
Incidence of Post-Operative CSF Leaks
90 Days
Incidence of Post-Operative Surgical Site Infections (SSIs)
90 Days
Study Arms (2)
Spinal Sealant System
EXPERIMENTALSpinal Sealant System
Standard of Care
ACTIVE COMPARATORStandard of care methods as an adjunct to sutured dural repair
Interventions
Eligibility Criteria
You may qualify if:
- Subjects scheduled for a spinal procedure that requires a dural incision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Medtronic - MITGcollaborator
Study Sites (1)
Confluent Surgical, Inc.
Bedford, Massachusetts, 01730, United States
Related Publications (1)
Wright NM, Park J, Tew JM, Kim KD, Shaffrey ME, Cheng J, Choudhri H, Krishnaney AA, Graham RS, Mendel E, Simmons N. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine (Phila Pa 1976). 2015 Apr 15;40(8):505-13. doi: 10.1097/BRS.0000000000000810.
PMID: 25646746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Medical Affairs
- Organization
- Integra LifeSciences
Study Officials
- STUDY DIRECTOR
Jen Doyle
Conlfuent Surgical/Covidien
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2007
First Posted
March 7, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
September 7, 2017
Results First Posted
August 21, 2012
Record last verified: 2014-09