Surgical Site InfectionPhase 4NCT01019447
The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection
A Phase 4 study testing Vicryl Plus and Vicryl in people with Surgical Site Infection, run by Cairo University at 2 sites in Egypt.
Trial summary
To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Vicryl Plus and Vicryl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 701 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2009to Mar 2011
- 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
- All patients of different age
- Gender
- Risk factors and procedures candidate for surgical intervention during the period of the study
Who cannot join
- Patients with an established pre-operative infection at the operative site
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Al-Zeraaein Hospital
Cairo, Cairo Governorate
Cairo University Kasr Al-Aini Hospital
Cairo, Cairo Governorate
About this study
Official title: "The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection" Prospective, Randomized, Controlled, Double Blind, Multi-centre Study.
To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.
- Conditions
- Surgical Site Infection
- Being tested
- Vicryl Plus, Vicryl
- Keywords
- Surgical site infection, Antimicrobial triclosan-coated polyglactin 910 suture, Length of hospital stay, SSI
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl PlusOther
Also called Triclosan-coated polyglactin 910 antimicrobial sutures
Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)
VicrylOther
Also called Polyglactin 910 antimicrobial sutures
Polyglactin 910 antimicrobial sutures (Vicryl)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used. Receives: Other: Vicryl Plus |
| Control group | Active comparator | The control group in which polyglactin 910 antimicrobial sutures will be used. Receives: Other: Vicryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria
Measured: 30 days (or 1 year in case of prosthesis)
Secondary outcomes (1)
Post-operative hospital stay in days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Amygate Healthcare
- Investigators
- Ibrahim Ga Ibrahim, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019447
- Sponsor's protocol ID
- INDV-0909001
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection" Prospective, Randomized, Controlled, Double Blind, Multi-centre Study.
- ClinicalTrials.gov ID
- NCT01019447
- Acronym / sponsor ID
- INDV-0909001
- Conditions
- Surgical Site Infection
- Keywords
- Surgical site infection, Antimicrobial triclosan-coated polyglactin 910 suture, Length of hospital stay, SSI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Amygate Healthcare
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Nov 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.
To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Vicryl PlusThe study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used. |
| Control group | Active comparator | Other: VicrylThe control group in which polyglactin 910 antimicrobial sutures will be used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients of different age
- Gender
- Risk factors and procedures candidate for surgical intervention during the period of the study
Key exclusion criteria (1 listed)
- Patients with an established pre-operative infection at the operative site
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 |
|---|---|---|
| Vicryl PlusAlso: Triclosan-coated polyglactin 910 antimicrobial suturesTriclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus) | Other | Study group |
| VicrylAlso: Polyglactin 910 antimicrobial suturesPolyglactin 910 antimicrobial sutures (Vicryl) | Other | Control group |
Primary outcome
Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria
Time frame: 30 days (or 1 year in case of prosthesis)
1 secondary outcome
Post-operative hospital stay in days
Time frame: 30 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 22 Jun 2011.
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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.
Ibrahim Ga Ibrahim, MD principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vicryl Plus and Vicryl in people with Surgical Site Infection, run by Cairo University at 2 sites in Egypt.
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 3 inclusion and 1 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 22 Jun 2011. 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 Egypt. 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?
Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria (time frame: 30 days (or 1 year in case of prosthesis)). 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 22 Jun 2011.