Suture Materials: an Evaluation

NCT ID: NCT03410433

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Suture Materials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Silk 4.0

Silk suture

Group Type ACTIVE_COMPARATOR

Silk 4.0

Intervention Type DEVICE

Silk suture 4.0

PG910 4.0

Vicryl Rapid suture

Group Type ACTIVE_COMPARATOR

PG 910 4.0

Intervention Type DEVICE

PG 910 4.0

PP 4.0

Non-absorbable polypropylene monofilament

Group Type EXPERIMENTAL

PP 4.0

Intervention Type DEVICE

PP 4.0

Silk 5.0

Silk suture

Group Type ACTIVE_COMPARATOR

Silk 5.0

Intervention Type DEVICE

Silk 5.0

PG910 5.0

Vicryl suture

Group Type ACTIVE_COMPARATOR

PG910 5.0

Intervention Type DEVICE

PG910 5.0

PP 5.0

Non-absorbable polypropylene monofilament

Group Type EXPERIMENTAL

PP 5.0

Intervention Type DEVICE

PP 5.0

APG 5.0

Antibacterial Vicryl suture

Group Type EXPERIMENTAL

APG 5.0

Intervention Type DEVICE

APG 5.0

ePTFE 5.0

expanded polytetrafluoroethylene

Group Type EXPERIMENTAL

ePTFE 5.0

Intervention Type DEVICE

ePTFE 5.0

Interventions

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Silk 4.0

Silk suture 4.0

Intervention Type DEVICE

PG 910 4.0

PG 910 4.0

Intervention Type DEVICE

PP 4.0

PP 4.0

Intervention Type DEVICE

Silk 5.0

Silk 5.0

Intervention Type DEVICE

PG910 5.0

PG910 5.0

Intervention Type DEVICE

PP 5.0

PP 5.0

Intervention Type DEVICE

APG 5.0

APG 5.0

Intervention Type DEVICE

ePTFE 5.0

ePTFE 5.0

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 36 patients
* in need for periodontal surgery
* patients in good general health
* able to sign IC form

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Quirynen

Role: STUDY_DIRECTOR

KU Leuven

Other Identifiers

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S58697

Identifier Type: -

Identifier Source: org_study_id

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