The Comparison of Microbial Adherence to Various Sutures in Patients Undergoing Oral Surgery

January 13, 2016 updated by: Hadassah Medical Organization

The final stage of any surgical procedure is suturing. Sutures have a vital rule in wound healing- they are responsible for flaps approximation, hemostasis and restoring function and esthetics.

Choosing the right suture is crucial especially in oral sites because of its unique anatomical features: the presence of saliva and the patient's everyday function- swallowing, talking, eating etc.

Sutures require certain physical properties such as tensile strength, dimensional stability, lack of memory, knot security and elasticity. One highly important quality is the ability to prevent or reduce bacterial adhesion and by that to prevent secondary infection. There are many kinds of sutures in the market- none of which contains all the ideal features.

The aim of the study is to compare the amount of bacterial adhesion to different kinds of sutures in patients undergoing periodontal surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The participates in the study are scheduled to go oral surgery: dental implantation, Guided bone regeneration, resective periodontal surgery, sinus elevation (both crestal or lateral).

All participates will sign an informed consent form and under the institutional ethics committee approval will go to through the operation.

Each surgery will include at least 4 Simple Interrupted Suture with even spacing of 5 mm from each other in the scheduled for operation and without changing the original treatment plan. Incision location is in the area of surgery and not in a distinct location. The four sutures that will be used are: silk, vicryl, nylon and polypropylene.

At suture removal, after 10 days, all sutures will be collected in a sterile tube containing PBS solution. Within 3 hours, the samples will be sowed on two blood agar media plates. One plate will be aerobic condition and the other in an-aerobic condition. After one week, the number of colonies will use to calculate the CFU- colony-forming units.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients designated for oral surgery with the possibility to perform at least 4 sutures, 5mm apart. The surgery will take place at the periodontology department, Dental faculty, Hadassah medical center.
  • Patients willing to participate in the study and sign an informed concerned form
  • Patients without systemic illness

Exclusion Criteria:

  • Diabetes, heart disease, immune deficiency, thrombocytopenia\ coagulation enzymes deficiency
  • Chronic alcohol consumption\ drug user
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: silk suture
Other: silk suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
Other Names:
  • selection of sutures
ACTIVE_COMPARATOR: vicryl suture
Other: vicryl suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
Other Names:
  • selection of sutures
ACTIVE_COMPARATOR: nylon suture
Other: nylon suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
Other Names:
  • selection of sutures
ACTIVE_COMPARATOR: polypropylene suture
Other: polypropylene suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
Other Names:
  • selection of sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial counts on blood agar plates from each suture will be quantified in CFU (colony-forming units) and expressed as total bacteria/suture
Time Frame: Outcome measure will be assessed 10 days after sample incubation for the different sutures obtained from each study participate
CFU from all four different sutures (silk, vicryl, nylon and polypropylene sutures) will be compared.
Outcome measure will be assessed 10 days after sample incubation for the different sutures obtained from each study participate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Dudu Polak, DMD, Department of Periodontology, Hadassah Medical Center, Jerusalem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 10, 2016

First Posted (ESTIMATE)

January 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HadassahMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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