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Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

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ClinicalTrials.gov Identifier: NCT00826410
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
Sponsor:
Information provided by:
University Hospital Freiburg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Digestive System Diseases [C06] Digestive System Neoplasms [C04.588.274] Device: Redon drain Phase 3

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
Study Start Date : May 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : January 2005

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 Name: subcutaneous suction drain according to Redon



Primary Outcome Measures :
  1. number of surgical site infections according to CDC guidelines after laparotomy in general surgery [ Time Frame: 30 days after operation ]

Secondary Outcome Measures :
  1. risk factors for surgical site infections [ Time Frame: 30 days after operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826410


Locations
Germany
Department of Visceral and General Surgery , University of Freiburg, Germany
Freiburg, BW, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Peter K Baier, MD Department of Visceral and General Surgery University of Freiburg, Germany

Responsible Party: PD.Dr Peter Baier, university of Freiburg
ClinicalTrials.gov Identifier: NCT00826410     History of Changes
Other Study ID Numbers: 230/02
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by University Hospital Freiburg:
Laparotomy
Surgical site infection
Drainage

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms