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

NCT ID: NCT00947089

Last Updated: 2009-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group A-the treatment group

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

Group Type EXPERIMENTAL

oxidized regenerated cellulose (Fibrillar SURGICEL)

Intervention Type DEVICE

one gauze made of ORC

group B-the control group

control group-patients have their wound wad with iodoform gauze

Group Type ACTIVE_COMPARATOR

iodoform gauze

Intervention Type DEVICE

one iodoform gauze

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oxidized regenerated cellulose (Fibrillar SURGICEL)

one gauze made of ORC

Intervention Type DEVICE

iodoform gauze

one iodoform gauze

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

UCSC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sergio Alfieri, MD

Role: STUDY_CHAIR

UCSC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Digestive Surgery of the Catholic University of Sacred Heart

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCSC 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.