Status:

COMPLETED

Role of Oxidized Regenerated Cellulose (ORC) Applied to "Dirty" Surgical Wounds

Lead Sponsor:

Catholic University of the Sacred Heart

Conditions:

Infections

Eligibility:

All Genders

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).

Detailed Description

Surgical site infections (SSI) have significant clinical and economic repercussions since they still are the most common cause of nosocomial infections in surgical patients. It is important to bear in...

Eligibility Criteria

Inclusion

  • have an ileostomy or a colostomy
  • are candidates for an elective surgical procedure of ostomy closure

Exclusion

  • immunodeficiency
  • chronic use of corticosteroids or antibiotics
  • chemotherapy and/or radiotherapy in the last 30 days before closure of the stoma
  • concomitant foci of infection

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT00947089

Start Date

December 1 2003

End Date

December 1 2008

Last Update

July 27 2009

Active Locations (1)

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Digestive Surgery of the Catholic University of Sacred Heart

Rome, Italy, 00168