A comparative study to assess efficacy and safety of suturing versus topical skin adhesive (n-butyl-2-cyanoacrylate) for portsite skin closure in patients undergoing laparoscopic surgery in a tertiary care hospital
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate incidence of surgical site infection using CDC criteria for SSI
研究概览
简要总结
Laparoscopic surgery has become the standard of care for surgical procedures across multiple specialties, reducing perioperative complications, accelerating recovery and
providing superior cosmetic results. Diagnostic and operative laparoscopies are among the most common procedures in gynecology. There is no ‘‘gold standard’’ for the method of wound closure in laparoscopic wounds. A variety of procedures is available such as transcutaneous suture, subcuticular suture, adhesive paper tape, skin staples and skin adhesives. The ideal wound closure material should permit a precise wound closure with reapproximation of wound. Sutures being a classic method of wound closure have many have certain disadvantage namely prolonged duration of surgery and anesthesia, tissue reactivity, risk of needle stick, undesirable trauma to the intact tissue on either side of the wound, permanent suture tracts, early removal which results in dehiscence, anxiety, and pain during removal. Tissue adhesive were invented in 1949 and tried clinically for the first time in 1959, which allows for normal wound healing and is accomplished without the need of local anesthesia or tissue injury. N-butyl-2-cynoacrylate in liquid solution is monomeric, application to tissue results in polymerization, resulting in a strong tissue bond that holds the wound edges together. Advantages of this adhesive over conventional wound closure techniques include easy to use, rapid application, patient comfort, excellent bacteriostatic property, resistant to infection, no risk of needle stick injury, decreased repair time, good hemostasis, eliminates recalled visits and has good short and long-term cosmetic outcome. Though the tissue adhesives were invented in mid 90’s, it is not been used frequently despite its remarkable advantages over traditional suturing, hence the purpose of this study is to compare the outcomes with n-butyl cyanoacrylate (Truseal) versus suturing (Trusynth plus neo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients willing to give written informed consent
- •Patients planned for total laparoscopic surgery in the Department of Obstetrics and Gynecology
- •Patients posted for Fibroid, Unresponsive perimenopausal hemorrhage, Adenomyosis, Perimenopausal women with AUB laparoscopic surgeries.
排除标准
- •Known or suspected gynecological malignancy
- •Patients with active pelvic infection
- •Patients unfit for pneumo-peritoneum or Trendelenburg position
- •Patient with known Coagulation disorder
- •Patients who have not given written informed consent.
结局指标
主要结局
To evaluate incidence of surgical site infection using CDC criteria for SSI
时间窗: Day of discharge Post-surgery day 10±3 Post-surgery day 30±7
次要结局
- To assess the time required for port closure in both the groups(Day of surgery)
- To evaluate wound pain using 10-point Visual Analog Scale (VAS) score(Day of discharge Post-surgery day 10±3 Post-surgery day 30±7)
- To Evaluate ease of application/usage using Product Usage Assessment Scale((using 5-point scale, with 5 being excellent and 1 being poor))
- To Evaluate patient’s satisfaction in both the groups (using 5-point scale, with 5 being excellent and 1 being poor)(Day of discharge Post-surgery day 10±3 Post-surgery day 30±7)
- To evaluate post-operative wound complications in both the groups(Day of discharge Post-surgery day 10±3 Post-surgery day 30±7)
- To assess Cosmetic appearance of the wound using Modified Hollander Wound Score(Day of discharge Post-surgery day 30±7)
- To evaluate adverse events among the two groups(Day of discharge Post-surgery day 10±3 Post-surgery day 30±7)
研究者
Dr Chaithanya T N
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara