CTRI/2020/04/024955已完成4 期
Single blind, randomized study comparing clinical equivalence of PD Synth and PDS, slowly absorbed polydioxanone sutures, for abdominal fascial closure following elective/emergency midline laparotomy
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects undergoing elective/emergency midline laparotomy
- •2. Male or female 18 to 60 years of age, with good systemic/ mental health as per opinion of investigator
- •3. Subjects with CDC surgical wound classification class I/II/III
- •4. Subjects who have given written informed consent
排除标准
- •1. ASA-V classified Subjects
- •2. Subjects who are pregnant or planning pregnancy in next one year
- •3. Subjects having life expectancy of less than one year duration
- •4. Subjects with BMI <18.5 and >=30
- •5. Subjects with history of midline laparotomy
- •6. Subjects undergoing elective/emergency laparoscopic abdominal surgeries
- •7. Subjects requiring an early (within 30 days) reintervention after index surgery
- •8. Subjects having active infection at or around the skin incision site
- •9. Subjects having a history of or presenting with an abdominal hernia
- •10. Subjects having abdominal wall metastases
- •11. Subjects needing prophylactic mesh augmentation after midline laparotomy
- •12. Subjects with history of allergy to polydioxanone or similar products
- •13. Subjects with history of systemic diseases such as COPD, tuberculosis, bleeding disorders.
- •14. Subjects who had the habit of drug abuse
- •15. Subjects already participating in another trial
- •16. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
- •17. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •18. 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
- •19. Other indication-based exclusion, in the opinion of investigator
研究者
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