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Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Redon drain
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive System Diseases [C06] focused on measuring Laparotomy, Surgical site infection, Drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

subcutaneous drain

Arm Description

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

Outcomes

Primary Outcome Measures

number of surgical site infections according to CDC guidelines after laparotomy in general surgery

Secondary Outcome Measures

risk factors for surgical site infections

Full Information

First Posted
January 20, 2009
Last Updated
January 20, 2009
Sponsor
University Hospital Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT00826410
Brief Title
Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
Official Title
Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Diseases [C06], Digestive System Neoplasms [C04.588.274]
Keywords
Laparotomy, Surgical site infection, Drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subcutaneous drain
Arm Type
Experimental
Arm Description
Use of subcutaneus suction drain ("Redon") after laparotomy
Intervention Type
Device
Intervention Name(s)
Redon drain
Other Intervention Name(s)
subcutaneous suction drain according to Redon
Intervention Description
subcutaneous suction drain after laparotomy for two days
Primary Outcome Measure Information:
Title
number of surgical site infections according to CDC guidelines after laparotomy in general surgery
Time Frame
30 days after operation
Secondary Outcome Measure Information:
Title
risk factors for surgical site infections
Time Frame
30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter K Baier, MD
Organizational Affiliation
Department of Visceral and General Surgery University of Freiburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Visceral and General Surgery , University of Freiburg, Germany
City
Freiburg
State/Province
BW
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

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Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

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