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

The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).

Completed

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Key information

Conditions

Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Digestive Surgery of the Catholic University of Sacred Heart

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxidized regenerated cellulose (Fibrillar SURGICEL)

Device

one gauze made of ORC

Other names: Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)

iodoform gauze

Device

one iodoform gauze

Primary outcomes

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

Time frame: third post-operative day

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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

Acronym: ORC

Important dates

Study start: 2003
Primary completion: 2008
Study completion: 2008
First posted: Jul 27, 2009
Registry last updated: Jul 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed