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Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00826410
First received: January 20, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Digestive System Diseases [C06]
Digestive System Neoplasms [C04.588.274]
 Device: Redon drain
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • number of surgical site infections according to CDC guidelines after laparotomy in general surgery [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • risk factors for surgical site infections [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2003
Study Completion Date: January 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: PD.Dr Peter Baier, university of Freiburg
ClinicalTrials.gov Identifier: NCT00826410     History of Changes
Other Study ID Numbers: 230/02
Study First Received: January 20, 2009
Last Updated: January 20, 2009
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on June 18, 2013