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

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00947089
First received: July 20, 2009
Last updated: July 24, 2009
Last verified: July 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Iodoform
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sergio Alfieri, UCSC
ClinicalTrials.gov Identifier: NCT00947089     History of Changes
Other Study ID Numbers: UCSC 1
Study First Received: July 20, 2009
Last Updated: July 24, 2009
Health Authority: United States: Food and Drug Administration
Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013