Colorectal CancerPhase 3AMNCT00981110
Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
A Phase 3 study testing AQUAGEL Ag Hydrofiber Wound Dressing and Mepore Self-adhesive absorbent dressing in people with Colorectal Cancer, run by European Institute of Oncology at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- AQUAGEL Ag Hydrofiber Wound Dressing and Mepore Self-adhesive absorbent dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2008to Dec 2010
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven)
- Age 18-75
- Informed signed consent
- Performance Status 0-2 (according to ECOG score)
- Platelets > 50.000/mm3
- Prothrombin Time (Quick) > 60%
- White Blood Cells > 2500/mm3
- Life Expectancy > 3 months
Who cannot join
- Intestinal obstruction
- Severe intestinal bleeding requiring blood transfusion
- Age under 18 or over 75
- Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
- Renal failure (hemodialysis, creatinin > 2.5 mg/dL)
- Active infections
Show all 9Show fewer
- Coagulopathy
- Inability to give an informed consent
- Known allergies to dressing components
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
European Institute of Oncology
Milan
S. Gerardo Hospital
Monza, Monza, 20052
About this study
Official title: Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.
- Conditions
- Colorectal Cancer
- Being tested
- AQUAGEL Ag Hydrofiber Wound Dressing, Mepore Self-adhesive absorbent dressing
- Keywords
- Surgical site infections (SSI), Advanced antimicrobial dressing and clean surgery, Hydrofibre dressing
- Medical subject headings
- Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUAGEL Ag Hydrofiber Wound DressingDevice
Also called AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)
Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure
Mepore Self-adhesive absorbent dressingDevice
Standard dressing: medication performed as for frequency and duration according standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Mepore Self-adhesive absorbent dressing | Active comparator | Mepore Self-adhesive absorbent dressing Receives: Device: Mepore Self-adhesive absorbent dressing |
| AQUAGEL Ag Hydrofiber Wound Dressing | Experimental | AQUAGEL Ag Hydrofiber Wound Dressing Receives: Device: AQUAGEL Ag Hydrofiber Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with a Surgical site infection
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Andreoni, MD, Principal investigator, European Institute of OncologyRoberto Biffi, MD, Principal investigator, European Institute of OncologyEmilio Bertani, MD, Principal investigator, European Institute of Oncolgy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981110
- Sponsor's protocol ID
- IEO S402/208
- Acronym
- AM
- Status last verified
- Sep 2012
- First submitted
- 31 Aug 2009
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Biffi R, Fattori L, Bertani E, Radice D, Rotmensz N, Misitano P, Cenciarelli S, Chiappa A, Tadini L, Mancini M, Pesenti G, Andreoni B, Nespoli A. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver. World J Surg Oncol. 2012 May 23;10:94. doi: 10.1186/1477-7819-10-94.
PubMed 22621779
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
- ClinicalTrials.gov ID
- NCT00981110
- Acronym / sponsor ID
- AM / IEO S402/208
- Conditions
- Colorectal Cancer
- Keywords
- Surgical site infections (SSI), Advanced antimicrobial dressing and clean surgery, Hydrofibre dressing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Sep 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 evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepore Self-adhesive absorbent dressing | Active comparator | Device: Mepore Self-adhesive absorbent dressingMepore Self-adhesive absorbent dressing |
| AQUAGEL Ag Hydrofiber Wound Dressing | Experimental | Device: AQUAGEL Ag Hydrofiber Wound DressingAQUAGEL Ag Hydrofiber Wound Dressing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven)
- Age 18-75
- Informed signed consent
- Performance Status 0-2 (according to ECOG score)
- Platelets > 50.000/mm3
Key exclusion criteria (9 listed)
- Intestinal obstruction
- Severe intestinal bleeding requiring blood transfusion
- Age under 18 or over 75
- Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
- Renal failure (hemodialysis, creatinin > 2.5 mg/dL)
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 |
|---|---|---|
| AQUAGEL Ag Hydrofiber Wound DressingAlso: AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure | Device | AQUAGEL Ag Hydrofiber Wound Dressing |
| Mepore Self-adhesive absorbent dressingStandard dressing: medication performed as for frequency and duration according standard procedure | Device | Mepore Self-adhesive absorbent dressing |
Primary outcome
The rate of patients with a Surgical site infection
Time frame: 30 days after surgery
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 11 Sep 2012.
- Derived from this study: PubMed 22621779Biffi R, Fattori L, Bertani E, Radice D, Rotmensz N, Misitano P, Cenciarelli S, Chiappa A, Tadini L, Mancini M, Pesenti G, Andreoni B, Nespoli A. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver. World J Surg Oncol. 2012 May 23;10:94. doi: 10.1186/1477-7819-10-94.
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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.
Bruno Andreoni, MD principal investigator
European Institute of Oncology
Roberto Biffi, MD principal investigator
European Institute of Oncology
Emilio Bertani, MD principal investigator
European Institute of Oncolgy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AQUAGEL Ag Hydrofiber Wound Dressing and Mepore Self-adhesive absorbent dressing in people with Colorectal Cancer, run by European Institute of Oncology at 2 sites 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 8 inclusion and 9 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 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The rate of patients with a Surgical site infection (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981110, which also lists 1 linked publication.
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 11 Sep 2012.