Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair (DREAM)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Incisional Hernia

Treatments: Drug: Tisseel®; Procedure: Drainage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00775034

2008/433

Details and patient eligibility

About

Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

1

Experimental group

Description:

Study group (Tisseel®)

Treatment:

Drug: Tisseel®

2

Other group

Description:

Control group

Treatment:

Procedure: Drainage