Laparoscopic SurgeryPhase 4NCT04255927
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
A Phase 4 study testing Coated Vicryl plus and Coated vicryl in people with Laparoscopic Surgery and Surgical Wound, run by ClinAmygate at 1 site in Egypt.
Trial summary
Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Surgery, Surgical Wound, Surgical Site Infection
- What is being tested?
- Coated Vicryl plus and Coated vicryl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2020to 20 Apr 2022
- 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
- candidate for laparoscopic surgical intervention during the period of the study were included.
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.
About this study
Official title: Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.
Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.
Read the detailed description
In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.
- Being tested
- Coated Vicryl plus, Coated vicryl
- Medical subject headings
- Surgical Wound, Surgical Wound Infection
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
Vicryl plus (Coated Polyglactin 910 with Triclosan)
Coated vicrylDrug
Also called Coated Polyglactin 910 without Triclosan
Vicryl (Coated Polyglactin 910 without Triclosan)
| Study group | Role | What they receive |
|---|---|---|
| Coated Polyglactin 910 with Triclosan | Experimental | Coated Polyglactin 910 with Triclosan Receives: Drug: Coated Vicryl plus |
| Coated Polyglactin 910 without Triclosan | Active comparator | Coated Polyglactin 910 without Triclosan Receives: Drug: Coated vicryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
port site infection (PSI)
the incidence of port site infection (PSI)
Measured: 30 days
Secondary outcomes (1)
hospital stay
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 posted5 Feb 2020
- Study start5 Feb 2020
- Primary completion10 Mar 2022
- Study completion20 Apr 2022
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 Laparoscopic SurgeryStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology, Al Safwa Hospital, Fayoum University Hospital
- Responsible party
- Principal investigator, Emad R Issak, Ain Shams University
- Investigators
- Emad R Issak, Diploma, Study director, ClinAmygate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255927
- Sponsor's protocol ID
- PR2019-26
- Status last verified
- May 2022
- First submitted
- 3 Feb 2020
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.
- ClinicalTrials.gov ID
- NCT04255927
- Acronym / sponsor ID
- PR2019-26
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology, Al Safwa Hospital, Fayoum University Hospital
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- 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 PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.
Detailed description
In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized-controlled
| Arm | Type | Receives |
|---|---|---|
| Coated Polyglactin 910 with Triclosan | Experimental | Drug: Coated Vicryl plusCoated Polyglactin 910 with Triclosan |
| Coated Polyglactin 910 without Triclosan | Active comparator | Drug: Coated vicrylCoated Polyglactin 910 without Triclosan |
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
- candidate for laparoscopic surgical intervention during the period of the study were included.
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 TriclosanVicryl plus (Coated Polyglactin 910 with Triclosan) | Drug | Coated Polyglactin 910 with Triclosan |
| Coated vicrylAlso: Coated Polyglactin 910 without TriclosanVicryl (Coated Polyglactin 910 without Triclosan) | Drug | Coated Polyglactin 910 without Triclosan |
Primary outcome
port site infection (PSI)
Time frame: 30 days
the incidence of port site infection (PSI)
1 secondary outcome
hospital stay
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 11 May 2022.
- 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 Coated vicryl in people with Laparoscopic Surgery 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: finished, as of the sponsor's last update on 11 May 2022. 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?
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?
port site infection (PSI) (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 NCT04255927, 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 May 2022.