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NCT00826410 Clinical Trial

Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Digestive System Diseases [C06] Clinical Trial

Official title:
Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00826410
Other study ID # 230/02
Secondary ID
Status Completed
Phase Phase 3
First received January 20, 2009
Last updated January 20, 2009
Start date May 2003
Est. completion date January 2005

Study information
Verified date January 2009
Source University Hospital Freiburg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date January 2005
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Redon drain
subcutaneous suction drain after laparotomy for two days

Locations
Country Name City State
Germany Department of Visceral and General Surgery , University of Freiburg, Germany Freiburg BW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of surgical site infections according to CDC guidelines after laparotomy in general surgery 30 days after operation Yes
Secondary risk factors for surgical site infections 30 days after operation No