Suture Materials: an Evaluation

Not Applicable

Completed

• Conditions: Suture Materials
• Interventions: Device: Silk 4.0; Device: PP 4.0; Device: PG910 5.0; Device: PG 910 4.0; Device: ePTFE 5.0; Device: Silk 5.0; Device: PP 5.0; Device: APG 5.0

• Registration Number: NCT03410433
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-01
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-24
• Last Update Submitted: 2018-01-24
• Study First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silk 4.0	Silk 4.0	Silk suture
PP 4.0	PP 4.0	Non-absorbable polypropylene monofilament
PG910 5.0	PG910 5.0	Vicryl suture
PG910 4.0	PG 910 4.0	Vicryl Rapid suture
ePTFE 5.0	ePTFE 5.0	expanded polytetrafluoroethylene
Silk 5.0	Silk 5.0	Silk suture
PP 5.0	PP 5.0	Non-absorbable polypropylene monofilament
APG 5.0	APG 5.0	Antibacterial Vicryl suture

Primary Outcome Measures

Name	Time	Method
Accumulation of soft deposits	7 to 14 days	Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots.

Secondary Outcome Measures

Name	Time	Method
Area of inflammation	7 to 14 days	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).
Microbial deposits on the sutures	7 to 14 days	The composition of the microbial deposits on the suture materials was examined with qPCR.