InfectionsPhase 4ORCNCT00947089
Role of Oxidized Regenerated Cellulose (ORC) Applied to "Dirty" Surgical Wounds
A Phase 4 study testing oxidized regenerated cellulose (Fibrillar SURGICEL) and iodoform gauze in people with Infections, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections
- What is being tested?
- oxidized regenerated cellulose (Fibrillar SURGICEL) and iodoform gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2003to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have an ileostomy or a colostomy
- are candidates for an elective surgical procedure of ostomy closure
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Digestive Surgery of the Catholic University of Sacred Heart
Rome, 00168
About this study
Official 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
The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).
Read the 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.
- Conditions
- Infections
- Being tested
- oxidized regenerated cellulose (Fibrillar SURGICEL), iodoform gauze
- Keywords
- ORC (oxidized regenerated cellulose), SSI (Surgical site infections)
- Medical subject headings
- Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxidized regenerated cellulose (Fibrillar SURGICEL)Device
Also called Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)
one gauze made of ORC
iodoform gauzeDevice
one iodoform gauze
| Study group | Role | What they receive |
|---|---|---|
| group A-the treatment group | Experimental | Group A-patients have their wound, the site of the previous stoma, wad with ORC Receives: Device: oxidized regenerated cellulose (Fibrillar SURGICEL) |
| group B-the control group | Active comparator | control group-patients have their wound wad with iodoform gauze Receives: Device: iodoform gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
Measured: third post-operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startDec 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- Sergio Alfieri, MD, Study chair, UCSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947089
- Sponsor's protocol ID
- UCSC 1
- Acronym
- ORC
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00947089
- Acronym / sponsor ID
- ORC / UCSC 1
- Conditions
- Infections
- Keywords
- ORC (oxidized regenerated cellulose), SSI (Surgical site infections)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A-the treatment group | Experimental | Device: oxidized regenerated cellulose (Fibrillar SURGICEL)Group A-patients have their wound, the site of the previous stoma, wad with ORC |
| group B-the control group | Active comparator | Device: iodoform gauzecontrol group-patients have their wound wad with iodoform gauze |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- have an ileostomy or a colostomy
- are candidates for an elective surgical procedure of ostomy closure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxidized regenerated cellulose (Fibrillar SURGICEL)Also: Fibrillar SURGICEL (Ethicon, Somerville, New Jersey)one gauze made of ORC | Device | group A-the treatment group |
| iodoform gauzeone iodoform gauze | Device | group B-the control group |
Primary outcome
to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
Time frame: third post-operative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Alfieri, MD study chair
UCSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxidized regenerated cellulose (Fibrillar SURGICEL) and iodoform gauze in people with Infections, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment (time frame: third post-operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2009.