Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

NCT ID: NCT00826410

Last Updated: 2009-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-01-31

Brief Summary

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The aim of the study is to determine wether subcutaneus suction drain (type redon-drain) protect against surgical side infection by laparotomy in general surgery.

Detailed Description

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If subcutan drains inserted during wound closudsure after laparotomy avoid subcutaneous haematoma and seromas by suction, these drains shout protect against surgical site infections. This is the ratio why such drain are in use in many countries. To test whether this hypothesis is true or not we pland this study.

Conditions

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Digestive System Diseases [C06] Digestive System Neoplasms [C04.588.274]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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subcutaneous drain

Use of subcutaneus suction drain ("Redon") after laparotomy

Group Type EXPERIMENTAL

Redon drain

Intervention Type DEVICE

subcutaneous suction drain after laparotomy for two days

Interventions

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Redon drain

subcutaneous suction drain after laparotomy for two days

Intervention Type DEVICE

Other Intervention Names

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subcutaneous suction drain according to Redon

Eligibility Criteria

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Inclusion Criteria

* indication for laparotomy
* age older 18 years
* informed consent

Exclusion Criteria

* organ transplantation
* operation for abdominal hernia
* appendectomy by McBurney incision
* redo-operation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Freiburg

OTHER

Sponsor Role lead

Responsible Party

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university of Freiburg

Principal Investigators

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Peter K Baier, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Visceral and General Surgery University of Freiburg, Germany

Locations

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Department of Visceral and General Surgery , University of Freiburg, Germany

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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230/02

Identifier Type: -

Identifier Source: org_study_id

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