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

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Completed
CT.gov ID
NCT00947089
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
60
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: oxidized regenerated cellulose (Fibrillar SURGICEL)
  • Device: iodoform gauze
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
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
Study Start Date :
Dec 1, 2003
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment [third post-operative day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00947089
    Other Study ID Numbers:
    • UCSC 1
    First Posted:
    Jul 27, 2009
    Last Update Posted:
    Jul 27, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    ORC (oxidized regenerated cellulose)
    SSI (Surgical site infections)
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Jul 27, 2009