CTRI/2020/09/027978已完成4 期
Single blind, randomized study comparing clinical equivalence of Trulon�® and Ethilon�® polyamide sutures, for closure of the skin following laparotomy incisions
Healthium Medtech Pvt Ltd0 个研究点目标入组 104 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
- 104
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. Women aged 18 to 50 years, undergoing laparotomy-based obstetric/ gynecological procedures
- •2. Women with CDC surgical wound classification class I/II
- •3. Women with good systemic/ mental health as per opinion of investigator
- •4. Subjects who have given written informed consent
排除标准
- •1. Women with BMI >30 Kg/m2
- •2. Women with hemoglobin levels <7g/dL
- •3. Women with a history of any laparotomy procedure or laparoscopic surgery
- •4. Women having urogenital tract infection within 2 weeks before the procedure
- •5. Women needing prophylactic mesh augmentation after laparotomy
- •6. Women undergoing elective/emergency laparoscopic abdominal surgeries
- •7. Women having active infection at or around the skin incision site
- •8. Women with history of allergy to nylon or similar products
- •9. Women already participating in another trial
- •10. Women unlikely to comply with the surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •11. Other indication-based exclusion, in opinion of investigator
研究者
相似试验
已完成
4 期
A clinical trial to compare tissue reaction/inflammation with Trusilk�® (Healthium) and Mersilk�® (Johnson & Johnson) silk sutures post primary closure of mucosa in subjects undergoing planned surgical removal of impacted mandibular third molar at 72 hours and 7 days.CTRI/2020/03/024100Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd132
已完成
4 期
Clinical equivalence study of two polydioxanone sutures (PD Synth and PDS) for abdominal fascial closure following midline laparotomyCTRI/2020/04/024955Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd96
已完成
4 期
A comparative clinical equivalence study of Trulene® and Prolene® polypropylene mesh in patients undergoing Lichtenstein open repair of primary inguinal hernia secured with sutures at 6 and 12 monthsCTRI/2020/02/023307Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd132
已完成
4 期
A clinical equivalence study of two polypropylene sutures (Trulene and Prolene) in elective primary coronary artery bypass graft surgeryCTRI/2020/05/025157Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd92
已完成
4 期
Comparative study of two suture materials (Monoglyde�® and Monocryl�®), for skin closure at cesarean deliveryCTRI/2020/06/025935Healthium Medtech Pvt Ltd132