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Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Phase 3
Completed
Conditions
Digestive System Diseases [C06]
Digestive System Neoplasms [C04.588.274]
Interventions
Device: Redon drain
Registration Number
NCT00826410
Lead Sponsor
University Hospital Freiburg
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
subcutaneous drainRedon drainUse of subcutaneus suction drain ("Redon") after laparotomy
Primary Outcome Measures
NameTimeMethod
number of surgical site infections according to CDC guidelines after laparotomy in general surgery30 days after operation
Secondary Outcome Measures
NameTimeMethod
risk factors for surgical site infections30 days after operation

Trial Locations

Locations (1)

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

🇩🇪

Freiburg, BW, Germany

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