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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947089
First Posted: July 27, 2009
Last Update Posted: July 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catholic University of the Sacred Heart
  Purpose
The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).

Condition Intervention Phase
Infections Device: oxidized regenerated cellulose (Fibrillar SURGICEL) Device: iodoform gauze Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of Oxidized Regenerated Cellulose in Preventing Infections at the Surgical Site: Prospective, Randomized Study in 98 Patients Affected by a Dirty Wound

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment [ Time Frame: third post-operative day ]

Enrollment: 98
Study Start Date: December 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group A-the treatment group
Group A-patients have their wound, the site of the previous stoma, wad with ORC
Device: oxidized regenerated cellulose (Fibrillar SURGICEL)
one gauze made of ORC
Other Name: Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)
Active Comparator: group B-the control group
control group-patients have their wound wad with iodoform gauze
Device: iodoform gauze
one iodoform gauze

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 mind the growing number of SSI due to antibiotic-resistant microorganisms.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947089


Locations
Italy
Digestive Surgery of the Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Study Chair: Sergio Alfieri, MD UCSC
  More Information

Responsible Party: Sergio Alfieri, UCSC
ClinicalTrials.gov Identifier: NCT00947089     History of Changes
Other Study ID Numbers: UCSC 1
First Submitted: July 20, 2009
First Posted: July 27, 2009
Last Update Posted: July 27, 2009
Last Verified: July 2009

Keywords provided by Catholic University of the Sacred Heart:
ORC (oxidized regenerated cellulose)
SSI (Surgical site infections)

Additional relevant MeSH terms:
Infection