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

Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947089
• Other study ID #: UCSC 1
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2009
• Last updated: July 24, 2009
• Start date: December 2003
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Infections

Intervention

Device:
• oxidized regenerated cellulose (Fibrillar SURGICEL)
one gauze made of ORC
• iodoform gauze
one iodoform gauze

Locations

Country	Name	City	State
Italy	Digestive Surgery of the Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment		third post-operative day	Yes