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

Primary Purpose

Infections

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
oxidized regenerated cellulose (Fibrillar SURGICEL)
iodoform gauze
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections focused on measuring ORC (oxidized regenerated cellulose), SSI (Surgical site infections)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Digestive Surgery of the Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A-the treatment group

group B-the control group

Arm Description

Group A-patients have their wound, the site of the previous stoma, wad with ORC

control group-patients have their wound wad with iodoform gauze

Outcomes

Primary Outcome Measures

to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment

Secondary Outcome Measures

Full Information

First Posted
July 20, 2009
Last Updated
July 24, 2009
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT00947089
Brief Title
Role of Oxidized Regenerated Cellulose (ORC) Applied to "Dirty" Surgical Wounds
Acronym
ORC
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections
Keywords
ORC (oxidized regenerated cellulose), SSI (Surgical site infections)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A-the treatment group
Arm Type
Experimental
Arm Description
Group A-patients have their wound, the site of the previous stoma, wad with ORC
Arm Title
group B-the control group
Arm Type
Active Comparator
Arm Description
control group-patients have their wound wad with iodoform gauze
Intervention Type
Device
Intervention Name(s)
oxidized regenerated cellulose (Fibrillar SURGICEL)
Other Intervention Name(s)
Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)
Intervention Description
one gauze made of ORC
Intervention Type
Device
Intervention Name(s)
iodoform gauze
Intervention Description
one iodoform gauze
Primary Outcome Measure Information:
Title
to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
Time Frame
third post-operative day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Alfieri, MD
Organizational Affiliation
UCSC
Official's Role
Study Chair
Facility Information:
Facility Name
Digestive Surgery of the Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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