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Suture Materials: an Evaluation

NCT03410433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-01-25

No results posted yet for this study

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. 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

Interventions

DEVICE

Silk 4.0

Silk suture 4.0

DEVICE

PG 910 4.0

PG 910 4.0

DEVICE

PP 4.0

PP 4.0

DEVICE

Silk 5.0

Silk 5.0

DEVICE

PG910 5.0

PG910 5.0

DEVICE

PP 5.0

PP 5.0

DEVICE

APG 5.0

APG 5.0

DEVICE

ePTFE 5.0

ePTFE 5.0

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Marc Quirynen · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-11-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410433 on ClinicalTrials.gov