Role of Oxidized Regenerated Cellulose (ORC) Applied to "... | NCT00947089

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

NCT00947089

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

Jul 27, 2009Estimated

Enrollment

98Actual

Phase

Phase 4

Conditions

Infections

Interventions

oxidized regenerated cellulose (Fibrillar SURGICEL)
iodoform gauze

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 20, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2009

Last Update Posted Date

Jul 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A-the treatment group	Experimental	Group A-patients have their wound, the site of the previous stoma, wad with ORC	Device: oxidized regenerated cellulose (Fibrillar SURGICEL)
group B-the control group	Active Comparator	control group-patients have their wound wad with iodoform gauze	Device: iodoform gauze

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxidized regenerated cellulose (Fibrillar SURGICEL)	Device	one gauze made of ORC	group A-the treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergio Alfieri, MD	UCSC	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Surgery of the Catholic University of Sacred Heart		Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided