NCT00947089

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

July 27, 2009

Status Verified

July 1, 2009

Enrollment Period

5 years

First QC Date

July 20, 2009

Last Update Submit

July 24, 2009

Conditions

Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    third post-operative day

Study Arms (2)

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

oxidized regenerated cellulose (Fibrillar SURGICEL)DEVICE

one gauze made of ORC

Also known as: Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)
group A-the treatment group
iodoform gauzeDEVICE

one iodoform gauze

group B-the control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • have an ileostomy or a colostomy
  • are candidates for an elective surgical procedure of ostomy closure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Surgery of the Catholic University of Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

InfectionsSurgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sergio Alfieri, MD

    UCSC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 27, 2009

Study Start

December 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 27, 2009

Record last verified: 2009-07

Locations

IT(1)