Incisional Surgical Site InfectionsPhase 3NCT02267122
Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection
A Phase 3 study testing ionic silver-containing dressing and Mupirocin ointment application in people with Incisional Surgical Site Infections, run by Hospital General Universitario Elche.
Trial summary
The patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incisional Surgical Site Infections
- What is being tested?
- ionic silver-containing dressing and Mupirocin ointment application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.
- Open surgical approach
Who cannot join
- Anastomotic leak
- Mortality
- Lost to follow-up
About this study
The patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery.
- Conditions
- Incisional Surgical Site Infections
- Being tested
- ionic silver-containing dressing, Mupirocin ointment application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ionic silver-containing dressingProcedure or surgery
After placing the staples, a ionic silver-containing dressing was placed covering the wound
Mupirocin ointment applicationProcedure or surgery
After placing the staples, Mupirocin ointment application over the wound was performed
| Study group | Role | What they receive |
|---|---|---|
| ionic silver-containing dressing | Experimental | After placing the staples, a ionic silver-containing dressing was placed covering the wound. Receives: Procedure: ionic silver-containing dressing |
| Mupirocin ointment application | Experimental | After placing the staples, a Mupirocin ointment application was placed covering the wound. Receives: Procedure: Mupirocin ointment application |
| Conventional dressing | No intervention | After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Surgical site infection
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
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 Incisional Surgical Site 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267122
- Sponsor's protocol ID
- Hospital General Elche
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
Publications
Ruiz-Tovar J, Llavero C, Morales V, Gamallo C. Total Occlusive Ionic Silver-Containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection. J Am Coll Surg. 2015 Aug;221(2):424-9. doi: 10.1016/j.jamcollsurg.2015.04.019. Epub 2015 Apr 28.
PubMed 26206641
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection
- ClinicalTrials.gov ID
- NCT02267122
- Acronym / sponsor ID
- Hospital General Elche
- Conditions
- Incisional Surgical Site Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Oct 2014 (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 patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ionic silver-containing dressing | Experimental | Procedure: ionic silver-containing dressingAfter placing the staples, a ionic silver-containing dressing was placed covering the wound. |
| Mupirocin ointment application | Experimental | Procedure: Mupirocin ointment applicationAfter placing the staples, a Mupirocin ointment application was placed covering the wound. |
| Conventional dressing | No intervention | –After placing the staples, a conventional dressing, without application of any special gauze or ointment, was placed covering the wound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.
- Open surgical approach
Key exclusion criteria (3 listed)
- Anastomotic leak
- Mortality
- Lost to follow-up
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 |
|---|---|---|
| ionic silver-containing dressingAfter placing the staples, a ionic silver-containing dressing was placed covering the wound | Procedure or surgery | ionic silver-containing dressing |
| Mupirocin ointment applicationAfter placing the staples, Mupirocin ointment application over the wound was performed | Procedure or surgery | Mupirocin ointment application |
Primary outcome
Incisional Surgical site infection
Time frame: 30 postoperative days
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 17 Oct 2014.
- Derived from this study: PubMed 26206641Ruiz-Tovar J, Llavero C, Morales V, Gamallo C. Total Occlusive Ionic Silver-Containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection. J Am Coll Surg. 2015 Aug;221(2):424-9. doi: 10.1016/j.jamcollsurg.2015.04.019. Epub 2015 Apr 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ionic silver-containing dressing and Mupirocin ointment application in people with Incisional Surgical Site Infections, run by Hospital General Universitario Elche.
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 3 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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Incisional Surgical site infection (time frame: 30 postoperative days). 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 NCT02267122, 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 17 Oct 2014.