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Completed

NCT Number: NCT00826410

Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

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.

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Key information

Conditions

Digestive System Diseases [C06] Digestive System Neoplasms [C04.588.274] Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Redon drain

Device

subcutaneous suction drain after laparotomy for two days

Other names: subcutaneous suction drain according to Redon

Primary outcomes

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

    Time frame: 30 days after operation

Secondary outcomes

  1. risk factors for surgical site infections

    Time frame: 30 days after operation

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Jan 22, 2009
Registry last updated
Jan 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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