Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00826410

Enrollment

200

Registered

2009-01-22

Start date

2003-05-31

Completion date

2005-01-31

Last updated

2009-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Diseases [C06], Digestive System Neoplasms [C04.588.274]

Keywords

Laparotomy, Surgical site infection, Drainage

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.

Interventions

DEVICERedon drain

subcutaneous suction drain after laparotomy for two days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
number of surgical site infections according to CDC guidelines after laparotomy in general surgery	30 days after operation

Secondary

Measure	Time frame
risk factors for surgical site infections	30 days after operation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026