Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery - Full Text View

Sponsored by:	University Hospital Freiburg
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00826410

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Digestive Diseases Surgery

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
subcutaneous drain: Experimental Use of subcutaneus suction drain ("Redon") after laparotomy	Device: Redon drain subcutaneous suction drain after laparotomy for two days

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

Keywords provided by University Hospital Freiburg:

Laparotomy
Surgical site infection
Drainage

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009