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临床试验/NCT02653924
NCT02653924Unknown不适用

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

Hadassah Medical Organization0 个研究点目标入组 30 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
bacterial counts on blood agar plates from each suture will be quantified in CFU (colony-forming units) and expressed as total bacteria/suture

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

silk suture

Active Comparator

silk suture

干预措施: silk suture (Other)

vicryl suture

Active Comparator

vicryl suture

干预措施: vicryl suture (Other)

nylon suture

Active Comparator

nylon suture

干预措施: nylon suture (Other)

polypropylene suture

Active Comparator

polypropylene suture

干预措施: polypropylene suture (Other)

结局指标

主要结局

bacterial counts on blood agar plates from each suture will be quantified in CFU (colony-forming units) and expressed as total bacteria/suture

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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