This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Catholic University of the Sacred Heart Identifier:
First received: July 20, 2009
Last updated: July 24, 2009
Last verified: July 2009
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: 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.

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00947089

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

Responsible Party: Sergio Alfieri, UCSC Identifier: NCT00947089     History of Changes
Other Study ID Numbers: UCSC 1
Study First Received: July 20, 2009
Last Updated: July 24, 2009

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

Additional relevant MeSH terms:
Infection processed this record on August 16, 2017