Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

University Hospital Freiburg

Status and phase: Completed; Phase 3

Conditions: Digestive System Neoplasms [C04.588.274]; Digestive System Diseases [C06]

Treatments: Device: Redon drain

Study type: Interventional

Funder types: Other

Identifiers

NCT00826410

230/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 1 patient group

subcutaneous drain

Experimental group

Description:

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

Treatment:

Device: Redon drain