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

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 4

Conditions: Infections

Treatments: Device: oxidized regenerated cellulose (Fibrillar SURGICEL); Device: iodoform gauze

Study type: Interventional

Funder types: Other

Identifiers

NCT00947089

UCSC 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

group A-the treatment group

Experimental group

Description:

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

Treatment:

Device: oxidized regenerated cellulose (Fibrillar SURGICEL)

group B-the control group

Active Comparator group

Description:

control group-patients have their wound wad with iodoform gauze

Treatment:

Device: iodoform gauze