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

The Role of Oxidized Regenerated Cellulose in Preventing Infections at the Surgical Site: Prospective, Randomized Study in 98 Patients Affected by a Dirty Wound

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00947089

Acronym

ORC

Enrollment

Registered

2009-07-27

Start date

2003-12-31

Completion date

2008-12-31

Last updated

2009-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections

Keywords

ORC (oxidized regenerated cellulose), SSI (Surgical site infections)

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.

Interventions

DEVICEoxidized regenerated cellulose (Fibrillar SURGICEL)

one gauze made of ORC

DEVICEiodoform gauze

one iodoform gauze

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026