Infection, Surgical SiteNCT03659344
Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study
A study testing Vicryl plus in people with Infection, Surgical Site, run by Shiraz University of Medical Sciences.
Trial summary
Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Surgical Site
- What is being tested?
- Vicryl plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Jul 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Need 3 dental implants at the posterior of the mandible
Who cannot join
- Diabetic patients
- smoker
- poor oral hygiene
About this study
Official title: Vicryl Plus and Vicryl Sutures in Reduce of Infection in Dental Implant Surgery
Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.
Read the detailed description
Patients were divided randomly based on computer randomization list in two groups: In group1, vicryl plus 4-0 (Vicryl Plus Ethicon,Johnson \& Johnson Company, Sommerville, NJ) suture was used to close surgical site and Vicryl 4-0 (Vicryl Ethicon,Johnson \& Johnson Company, Sommerville, NJ) in group II.
All dental implants were placed through creating subperiosteal flaps. In each group, fresh socket placed dental implants were documented. Patients were visited in 1, 2, 3 and 4 weeks after dental implant surgeries.
Postoperative infection was defined as local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site. If wound dehiscence occurred, it was documented.
Patients were blind about what suture was used.
- Conditions
- Infection, Surgical Site
- Being tested
- Vicryl plus
- Keywords
- sutures, Surgical Wound Infection, Polyglactin 910
- 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 plusDrug
Using vicryl sutures which coated with triclosan (antibiotic)
| Study group | Role | What they receive |
|---|---|---|
| Vicryl plus | Active comparator | In this group, vicryl plus(Triclosan coated) sutures were used to close flaps Receives: Drug: Vicryl plus |
| vicryl | No intervention | In this group, vicryl sutures were used to close flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of post-operative infection
The number of participants who had local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site.
Measured: In one month
The prevalence of post-operative dehiscence
The number of participants who had relatively or completely open wound
Measured: In one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Sep 2016
- Primary completion1 Feb 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Surgical SiteStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In group1, vicryl plus suture was used to close flaps. In group2,vicryl was used to close flaps
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Reza Tabrizi, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659344
- Sponsor's protocol ID
- IR.SBMU.RIDS.REC.1395.336
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vicryl Plus and Vicryl Sutures in Reduce of Infection in Dental Implant Surgery
- ClinicalTrials.gov ID
- NCT03659344
- Acronym / sponsor ID
- IR.SBMU.RIDS.REC.1395.336
- Conditions
- Infection, Surgical Site
- Keywords
- sutures, Surgical Wound Infection, Polyglactin 910
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 6 Sep 2018 (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.
Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.
Detailed description
Patients were divided randomly based on computer randomization list in two groups: In group1, vicryl plus 4-0 (Vicryl Plus Ethicon,Johnson \& Johnson Company, Sommerville, NJ) suture was used to close surgical site and Vicryl 4-0 (Vicryl Ethicon,Johnson \& Johnson Company, Sommerville, NJ) in group II.
All dental implants were placed through creating subperiosteal flaps. In each group, fresh socket placed dental implants were documented. Patients were visited in 1, 2, 3 and 4 weeks after dental implant surgeries.
Postoperative infection was defined as local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site. If wound dehiscence occurred, it was documented.
Patients were blind about what suture was used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In group1, vicryl plus suture was used to close flaps. In group2,vicryl was used to close flaps
| Arm | Type | Receives |
|---|---|---|
| Vicryl plus | Active comparator | Drug: Vicryl plusIn this group, vicryl plus(Triclosan coated) sutures were used to close flaps |
| vicryl | No intervention | –In this group, vicryl sutures were used to close flaps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Need 3 dental implants at the posterior of the mandible
Key exclusion criteria (3 listed)
- Diabetic patients
- smoker
- poor oral hygiene
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 plusUsing vicryl sutures which coated with triclosan (antibiotic) | Drug | Vicryl plus |
Primary outcome
The prevalence of post-operative infection
Time frame: In one month
The number of participants who had local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site.
The prevalence of post-operative dehiscence
Time frame: In one month
The number of participants who had relatively or completely open wound
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 6 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl plus in people with Infection, Surgical Site, run by Shiraz University of Medical Sciences.
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 1 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 6 Sep 2018. 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.
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 prevalence of post-operative infection (time frame: In one month). The study lists 2 primary outcomes in all. 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 6 Sep 2018.