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Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery


Phase 3
18 Years
N/A
Not Enrolling
Both
Digestive System Diseases [C06], Digestive System Neoplasms [C04.588.274]

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Trial Information

Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

30 days after operation

Safety Issue:

Yes

Principal Investigator

Peter K Baier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Visceral and General Surgery University of Freiburg, Germany

Authority:

Germany: Ethics Commission

Study ID:

230/02

NCT ID:

NCT00826410

Start Date:

May 2003

Completion Date:

January 2005

Related Keywords:

  • Digestive System Diseases [C06]
  • Digestive System Neoplasms [C04.588.274]
  • Laparotomy
  • Surgical site infection
  • Drainage
  • Neoplasms
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms

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