Suture Materials: an Evaluation

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Suture Materials

Treatments: Device: PG910 5.0; Device: Silk 4.0; Device: PP 5.0; Device: APG 5.0; Device: PP 4.0; Device: ePTFE 5.0; Device: PG 910 4.0; Device: Silk 5.0

Study type: Interventional

Funder types: Other

Identifiers

NCT03410433

S58697

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 8 patient groups

Silk 4.0

Active Comparator group

Description:

Silk suture

Treatment:

Device: Silk 4.0

PG910 4.0

Active Comparator group

Description:

Vicryl Rapid suture

Treatment:

Device: PG 910 4.0

PP 4.0

Experimental group

Description:

Non-absorbable polypropylene monofilament

Treatment:

Device: PP 4.0

Silk 5.0

Active Comparator group

Description:

Silk suture

Treatment:

Device: Silk 5.0

PG910 5.0

Active Comparator group

Description:

Vicryl suture

Treatment:

Device: PG910 5.0

PP 5.0

Experimental group

Description:

Non-absorbable polypropylene monofilament

Treatment:

Device: PP 5.0

APG 5.0

Experimental group

Description:

Antibacterial Vicryl suture

Treatment:

Device: APG 5.0

ePTFE 5.0

Experimental group

Description:

expanded polytetrafluoroethylene

Treatment:

Device: ePTFE 5.0