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Suture Materials: an Evaluation

U

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

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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