NCT00826410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

1.6 years

First QC Date

January 20, 2009

Last Update Submit

January 20, 2009

Conditions

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

Keywords

LaparotomySurgical site infectionDrainage

Outcome Measures

Primary Outcomes (1)

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

    30 days after operation

Secondary Outcomes (1)

  • risk factors for surgical site infections

    30 days after operation

Study Arms (1)

subcutaneous drain

EXPERIMENTAL

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

Device: Redon drain

Interventions

Redon drainDEVICE

subcutaneous suction drain after laparotomy for two days

Also known as: subcutaneous suction drain according to Redon
subcutaneous drain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for laparotomy
  • age older 18 years
  • informed consent

You may not qualify if:

  • organ transplantation
  • operation for abdominal hernia
  • appendectomy by McBurney incision
  • redo-operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter K Baier, MD

    Department of Visceral and General Surgery University of Freiburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

May 1, 2003

Primary Completion

December 1, 2004

Study Completion

January 1, 2005

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

DE(1)