Prospective Study on the Value of Subcutaneous Drains in... | NCT00826410

Studies
Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery

NCT00826410

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Jan 22, 2009Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

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

Interventions

Redon drain

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Dec 2004Actual

Completion Date

Jan 2005Actual

First Submitted Date

Jan 20, 2009

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2009

Last Update Posted Date

Jan 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subcutaneous drain	Experimental	Use of subcutaneus suction drain ("Redon") after laparotomy	Device: Redon drain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Redon drain	Device	subcutaneous suction drain after laparotomy for two days	subcutaneous drain

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter K Baier, MD	Department of Visceral and General Surgery University of Freiburg, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral and General Surgery , University of Freiburg, Germany		Freiburg im Breisgau	Baden-Wurttemberg	79106	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

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Browse Branches

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