Suture MaterialsNCT03410433
Suture Materials: an Evaluation
A study testing Silk 4.0, PG 910 4.0 and PP 4.0 in people with Suture Materials, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Suture Materials
- What is being tested?
- Silk 4.0, PG 910 4.0 and PP 4.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Nov 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 36 patients
- in need for periodontal surgery
- patients in good general health
- able to sign IC form
Who cannot join
- patients that were deemed unlikely to comply with the study protocol, as judged by the examiner
- patients who had a present alcohol and/or drug abuse
About this study
Official title: Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.
Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.
Material \& methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.
- Conditions
- Suture Materials
- Being tested
- Silk 4.0, PG 910 4.0, PP 4.0, Silk 5.0, PG910 5.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk 4.0Device
Silk suture 4.0
PG 910 4.0Device
PG 910 4.0
PP 4.0Device
PP 4.0
Silk 5.0Device
Silk 5.0
PG910 5.0Device
PG910 5.0
PP 5.0Device
PP 5.0
APG 5.0Device
APG 5.0
ePTFE 5.0Device
ePTFE 5.0
| Study group | Role | What they receive |
|---|---|---|
| Silk 4.0 | Active comparator | Silk suture Receives: Device: Silk 4.0 |
| PG910 4.0 | Active comparator | Vicryl Rapid suture Receives: Device: PG 910 4.0 |
| PP 4.0 | Experimental | Non-absorbable polypropylene monofilament Receives: Device: PP 4.0 |
| Silk 5.0 | Active comparator | Silk suture Receives: Device: Silk 5.0 |
| PG910 5.0 | Active comparator | Vicryl suture Receives: Device: PG910 5.0 |
| PP 5.0 | Experimental | Non-absorbable polypropylene monofilament Receives: Device: PP 5.0 |
| APG 5.0 | Experimental | Antibacterial Vicryl suture Receives: Device: APG 5.0 |
| ePTFE 5.0 | Experimental | expanded polytetrafluoroethylene Receives: Device: ePTFE 5.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of soft deposits
Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots.
Measured: 7 to 14 days
Secondary outcomes (2)
Area of inflammation
Clinical photographs were taken, calibrated with a ruler of 0.5 mm accuracy as is illustrated in Figure 2, before and after suture removal in both parts of the clinical study. Subsequently, the area of inflammation surrounding the sutures was measured by two separate examiners using the image-analysis program, Image J® (NIH, Bethesda, Maryland, USA).
Measured: 7 to 14 days
Microbial deposits on the sutures
The composition of the microbial deposits on the suture materials was examined with qPCR.
Measured: 7 to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study startFeb 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture MaterialsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Quirynen, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410433
- Sponsor's protocol ID
- S58697
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
- ClinicalTrials.gov ID
- NCT03410433
- Acronym / sponsor ID
- S58697
- Conditions
- Suture Materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Jan 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.
Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.
Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.
Material \& methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Silk 4.0 | Active comparator | Device: Silk 4.0Silk suture |
| PG910 4.0 | Active comparator | Device: PG 910 4.0Vicryl Rapid suture |
| PP 4.0 | Experimental | Device: PP 4.0Non-absorbable polypropylene monofilament |
| Silk 5.0 | Active comparator | Device: Silk 5.0Silk suture |
| PG910 5.0 | Active comparator | Device: PG910 5.0Vicryl suture |
| PP 5.0 | Experimental | Device: PP 5.0Non-absorbable polypropylene monofilament |
| APG 5.0 | Experimental | Device: APG 5.0Antibacterial Vicryl suture |
| ePTFE 5.0 | Experimental | Device: ePTFE 5.0expanded polytetrafluoroethylene |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 36 patients
- in need for periodontal surgery
- patients in good general health
- able to sign IC form
Key exclusion criteria (2 listed)
- patients that were deemed unlikely to comply with the study protocol, as judged by the examiner
- patients who had a present alcohol and/or drug abuse
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 |
|---|---|---|
| Silk 4.0Silk suture 4.0 | Device | Silk 4.0 |
| PG 910 4.0PG 910 4.0 | Device | PG910 4.0 |
| PP 4.0PP 4.0 | Device | PP 4.0 |
| Silk 5.0Silk 5.0 | Device | Silk 5.0 |
| PG910 5.0PG910 5.0 | Device | PG910 5.0 |
| PP 5.0PP 5.0 | Device | PP 5.0 |
| APG 5.0APG 5.0 | Device | APG 5.0 |
| ePTFE 5.0ePTFE 5.0 | Device | ePTFE 5.0 |
Primary outcome
Accumulation of soft deposits
Time frame: 7 to 14 days
Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots.
2 secondary outcomes
Area of inflammation
Time frame: 7 to 14 days
Microbial deposits on the sutures
Time frame: 7 to 14 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 25 Jan 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.
Marc Quirynen study director
KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Silk 4.0, PG 910 4.0 and PP 4.0 in people with Suture Materials, run by Universitaire Ziekenhuizen KU Leuven.
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 4 inclusion and 2 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 25 Jan 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?
Accumulation of soft deposits (time frame: 7 to 14 days). 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 25 Jan 2018.