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临床试验/CTRI/2023/06/054038
CTRI/2023/06/054038尚未招募不适用

A Prospective Study for analysis of Incidence of Surgical Site Infection in Hernia Meshplasty patients & To Study Risk Factors causing Surgical Site Infection.

BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年6月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
125
试验地点
1
主要终点
Development of surgical site infection

研究概览

简要总结

Treatment of Hernia has got modified last few decades. Initially locally available tissue were used for hernia surgery. It was then called as Herniorrhaphy. Later on Mesh were introduced for treatment of hernia surgery. Use of mesh revolutionized the management of hernia surgery. Mesh reduced the chances of recurrence of hernia as compared to tissue based repair. Use of Mesh during surgery is labelled as Mesh Hernioplasty surgery. And Mesh hernioplasty has become standard of care procedure for treatment of all hernia cases. Therefore, Mesh hernioplasty is the most common surgery performed for all types of hernia.

Polypropylene mesh is one of the most versatile mesh to be used during surgery. It is resistant to infection. It can withstand mild infection and it can be preserved in our body in spite of getting infection. Therefore, it is the preferred mesh used in all types of hernia surgery.

Use of any synthetic prosthesis implantation in our body is invariably associated with risk of developing a prosthetic infection. However, chances of infection associated with polypropylene mesh hernioplasty is very low. Traditionally it is described in literature as approximately 5%. Such infection may manifest in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus. Development of infection may leads to increased morbidity. Occasionally there may be a need of removal of mesh to cure the infection.

 This study envisages to check rate of surgical site infections in patients operated for hernia meshplasty surgery and to look forrisk factors for infections in patients operated for mesh hernioplasty. Primary objective being analysis of incidence of surgical site infection (SSI) in patients operated for hernia meshplasty. Secondary objective being to assess risk factors for surgical site infection in cases operated for hernia meshplasty

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • whom above 18 years of age, undergoing Polypropylene mesh repair for hernia.

排除标准

  • 1.Failure of consent 2.Patients having ascites 3.Patients on immunosuppressant.

结局指标

主要结局

Development of surgical site infection

时间窗: 90 days post surgery

次要结局

  • 1.Mean hospitalization time(2.Readmission in hospital)

研究者

发起方
BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL
申办方类型
Other [CENTRAL GOVERNMENT HOSPITAL]

研究点 (1)

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