DRainage versus sEAlant in prospective, Monocentric, double blinded randomized trial to evaluate the effect of fibrin glue in surgical repair of incisional hernias (DREAM-trial) - DREAM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004113-96-BE

Enrollment

Registered

2008-08-29

Start date

2008-09-17

Completion date

Unknown

Last updated

2018-07-23

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

Conditions

Open incisional hernia mesh repair

Interventions

Trade Name: Tissucol Duo 500 Product Name: Tissucol Pharmaceutical Form: Sealant INN or Proposed INN: APROTININ CAS Number: 9004040 Concentration unit: KIU/ml kallikrein inactivator unit/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - written informed consent from the patient. - incisional hernia larger than 5cm in diameter requiring elective surgical repair. - the diameter will be estimated pre-operatively and confirmed intra-operatively. The intra-operative measure be the definite value. - only primary incisional hernias will be considered. - A retromuscular preperitoneal mesh repair should be the intention to repair the hernia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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
Main Objective: To compare the use of Tissucol® Duo 500 in open incisional hernia mesh repair ;Secondary Objective: ;Primary end point(s): - primary: hospital stay - secondary: o postoperative drainage volume day 0,1, 2, 3 … and at day of removal. o perioperative morbidity rate. o pain measured using VAS daily till discharge and after 3 weeks post-surgery with preoperative VAS measurement. o McGill pain questionnaire preoperatively, at time of discharge, 2 weeks, 6 weeks and 1 year. o 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. o quality of life by EQ-5D, questionnaire preoperatively, after 2 weeks, 6 weeks and 1 year post surgery. o recurrence at one year	—

Measure

Time frame

Main Objective: To compare the use of Tissucol® Duo 500 in open incisional hernia mesh repair ;Secondary Objective: ;Primary end point(s): - primary: hospital stay - secondary: o postoperative drainage volume day 0,1, 2, 3 … and at day of removal. o perioperative morbidity rate. o pain measured using VAS daily till discharge and after 3 weeks post-surgery with preoperative VAS measurement. o McGill pain questionnaire preoperatively, at time of discharge, 2 weeks, 6 weeks and 1 year. o 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. o quality of life by EQ-5D, questionnaire preoperatively, after 2 weeks, 6 weeks and 1 year post surgery. o recurrence at one year

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026