Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775034

Acronym

DREAM

Enrollment

Registered

2008-10-17

Start date

2010-01-27

Completion date

2018-05-24

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

Brief summary

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

Interventions

DRUGTisseel®

Mesh repair for open incisional hernia repair with fibrin sealant

PROCEDUREDrainage

Mesh repair for open incisional hernia repair with drainage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Hospital stay	At time of discharge

Secondary

Measure	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	Daily till discharge and after 3 weeks post-surgery
Quality of life by SF-36 questionnaire	Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery
Recurrence	At one year

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026