Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

January 20, 2009 updated by: University Hospital Freiburg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Freiburg, BW, Germany, 79106
        • Department of Visceral and General Surgery , University of Freiburg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subcutaneous drain
Use of subcutaneus suction drain ("Redon") after laparotomy
Device: Redon drain
subcutaneous suction drain after laparotomy for two days
Other Names:
  • subcutaneous suction drain according to Redon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of surgical site infections according to CDC guidelines after laparotomy in general surgery
Time Frame: 30 days after operation
30 days after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
risk factors for surgical site infections
Time Frame: 30 days after operation
30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Investigators

  • Principal Investigator: Peter K Baier, MD, Department of Visceral and General Surgery University of Freiburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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