Single blind, randomized study comparing clinical equivalence of TruleneÂ® and ProleneÂ® polypropylene mesh, in subjects undergoing Lichtenstein open repair of primary inguinal hernia secured with sutures

Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd0 个研究点目标入组 132 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1. Males aged between 18-70 years of age with good systemic/ mental health as per opinion of investigator
•2. Subjects with the presence of uncomplicated primary inguinal hernia requiring elective surgery with mesh fixation
•3. Subjects with ASA grade 1 or grade 2
•4. Subjects who have given written informed consent
•5. Subjects with no previous history of anterior mesh hernia repair

•1. Subjects with BMI >=35
•2. Subjects having life expectancy of less than one year (52 weeks) duration
•3. Subjects requiring emergency surgical procedures
•4. Subjects undergoing elective/emergency laparoscopic inguinal hernioplasty
•5. Subjects having active infection at or around the skin incision site
•6. Subjects who are unable to walk 500 meters.
•7. Subjects with a prior mesh in the abdominal wall
•8. Subjects having bilateral inguinal hernia or recurrence of hernia
•9. Subjects having femoral hernia and strangulated hernia
•10. Subjects with history of allergy to polypropylene or similar products
•11. Subjects with history of tuberculosis, intractable chronic cough, bleeding disorders, osteoporosis, unstable or life-threatening conditions, history of cancer or in the process of cancer treatment, radiotherapy in pelvic area, known immunodeficiency or immunosuppression
•12. Subjects already participating in another surgical study
•13. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
•14. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
•15. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
•16. Other indication-based exclusion, in opinion of investigator

发起方

Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd