Surgical Site InfectionPhase 4NCT04256824
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds
A Phase 4 study testing coated vicryl plus and Vicryl in people with Surgical Site Infection and Surgical Wound, run by ClinAmygate at 1 site in Egypt.
Trial summary
Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Site Infection, Surgical Wound, Surgical Wound Infection
- What is being tested?
- coated vicryl plus and Vicryl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2020to 30 Jan 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18-75
- clean-contaminated wound surgery
Who cannot join
- Patient has immunodeficiency disorder.
- Patient receiving anti-cancer / immunosuppressive therapy.
- Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Misr Univeristy for Science and Technology Hospital
Giza
Moatasem-Bellah A Erfaan, MD, 01223478555, mustmedicine@gmail.com
About this study
Official title: Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study
Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery
Read the detailed description
Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.
- Being tested
- coated vicryl plus, Vicryl
- Medical subject headings
- Surgical Wound Infection, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coated vicryl plusDrug
Also called Coated Polyglactin 910 with Triclosan
Coated Polyglactin 910 with Triclosan (coated vicryl plus)
VicrylDrug
Also called Coated Polyglactin 910 without Triclosan
Coated Polyglactin 910 without Triclosan (vicryl)
| Study group | Role | What they receive |
|---|---|---|
| Coated Polyglactin 910 with Triclosan | Experimental | Coated vicryl plus Receives: Drug: coated vicryl plus |
| Coated Polyglactin 910 without Triclosan | Active comparator | Coated vicryl Receives: Drug: Vicryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
Incidence of surgical site infection within 30 days
Measured: 30 days
Secondary outcomes (1)
Hospital stay
duration of hospital stay
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 posted5 Feb 2020
- Study start5 Feb 2020
- Primary completion10 Oct 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
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 Surgical Site InfectionStudies 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
- Model description
- randomized-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology, Al Safwa Hospital, Al Zohour Hospital, Al-Menia Univeristy Hospital, MSKMC Univeristy Hospital
- Responsible party
- Sponsor
- Investigators
- Emad R Issak, Diploma, Study director, ClinAmygate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256824
- Sponsor's protocol ID
- PR2019-27
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjopen-2019-029727.
PubMed 31481559
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study
- ClinicalTrials.gov ID
- NCT04256824
- Acronym / sponsor ID
- PR2019-27
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology, Al Safwa Hospital, Al Zohour Hospital, Al-Menia Univeristy Hospital, MSKMC Univeristy Hospital
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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.
Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery
Detailed description
Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Coated Polyglactin 910 with Triclosan | Experimental | Drug: coated vicryl plusCoated vicryl plus |
| Coated Polyglactin 910 without Triclosan | Active comparator | Drug: VicrylCoated vicryl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age: 18-75
- clean-contaminated wound surgery
Key exclusion criteria (3 listed)
- Patient has immunodeficiency disorder.
- Patient receiving anti-cancer / immunosuppressive therapy.
- Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from 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 |
|---|---|---|
| coated vicryl plusAlso: Coated Polyglactin 910 with TriclosanCoated Polyglactin 910 with Triclosan (coated vicryl plus) | Drug | Coated Polyglactin 910 with Triclosan |
| VicrylAlso: Coated Polyglactin 910 without TriclosanCoated Polyglactin 910 without Triclosan (vicryl) | Drug | Coated Polyglactin 910 without Triclosan |
Primary outcome
Incidence of surgical site infection
Time frame: 30 days
Incidence of surgical site infection within 30 days
1 secondary outcome
Hospital stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Results publication: PubMed 31481559Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjopen-2019-029727.
- Individual participant dataSharing planned: No
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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.
Emad R Issak, Diploma study director
ClinAmygate
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 coated vicryl plus and Vicryl in people with Surgical Site Infection and Surgical Wound, run by ClinAmygate at 1 site 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 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emad R Issak, Diploma (00201272228989, dr.emad.r.h.issak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: 30 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 NCT04256824, 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 6 Sep 2023.