Drainage Versus Sealant in Double Blinded Monocentric Ope... | NCT00775034

Studies
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

NCT00775034

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jun 26, 2018Actual

Enrollment

57Actual

Phase

Phase 4

Conditions

Incisional Hernia

Interventions

Tisseel®
Drainage

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2010Actual

Primary Completion Date

Oct 14, 2014Actual

Completion Date

May 24, 2018Actual

First Submitted Date

Oct 16, 2008

First Submission Date that Met QC Criteria

Oct 16, 2008

First Posted Date

Oct 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2018

Last Update Posted Date

Jun 26, 2018Actual

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Study group (Tisseel®)	Drug: Tisseel®
2	Other	Control group	Procedure: Drainage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tisseel®	Drug	Mesh repair for open incisional hernia repair with fibrin sealant	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital stay		At time of discharge

Secondary Outcomes

Measure	Description	Time Frame
Postoperative drainage volume		Day 0,1, 2, 3 ? and at day of removal
Perioperative morbidity rate		At time of discharge
Pain measured using VAS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with a large incisional hernia >5cm diameter that needs elective repair with mesh augmentation

Exclusion Criteria:

no written informed consent
'hostile' abdomen
emergency surgery (incarcerated hernia)
parastomal hernia
incisional hernia outside the midline
recurrent incisional hernia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Berrevoet, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium
UZ gasthuisberg Leuven

Label	URL
Website of the University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015718	Fibrin Tissue Adhesive
D004322	Drainage

Ancestor Terms

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided