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临床试验/CTRI/2024/03/064150
CTRI/2024/03/064150尚未招募Unknown

Comparison of Wound Outcome in Subcutaneous Negative Suction Drain V/S Subcutaneous Corrugated Rubber Drain in Closure Of Midline Incision in Patients Undergoing Emergency Laparotomy for Perforation Peritonitis

All India Institute of Medical sciences Raipur1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
54
试验地点
1
主要终点
To compare Seroma formation, Hematoma and superficial wound dehiscence and need for intervention in both the study groups.

研究概览

简要总结

Perforation peritonitis is one of the commonest emergencies encountered by the surgeons.It is associated with highest rate of infective complication specially surgical site infection because there is contamination of Operative field with micro organism from endogenous source. The existing practice of closure of midline laparotomy wound is that after closing the rectus sheath either subcutaneous tissue is closed with absorbable sutures followed by skin closure with non-absorbable suture or the skin is closed with non absorbable sutures after closing the rectus sheath directly.

Here, In this study, a drain (negative suction drain or corrugated drain) in the subcutaneous plane will be placed and then skin to be closed.

Many times it has been seen that blood or fluid get collected in the subcutaneous space and this either just oozes out from the midline wound or stays in the plane for a long time. It is apprehended that this collected fluid or blood could be a nidus for the growth of organisms leading to surgical site infections. Applying drain will be helpful for removal of this collection and can potentially reduce the risk of SSI.

The selection of an appropriate drain type is crucial for achieving optimal wound healing outcomes. Negative suction drains are designed to actively remove fluids from the wound site using a vacuum system, while corrugated rubber drains passively collect fluids through capillary action.

It is anticipated that this study will provide valuable insights into the comparative effectiveness of negative suction drain versus corrugated rubber drain in subcutaneous space in preventing surgical site infection. The results may influence in selecting the most appropriate drain type based on wound healing outcomes, patient comfort, and satisfaction. Ultimately, this research aims to optimize postoperative care and enhance patient outcomes in surgical procedures requiring subcutaneous drainage.

Previous studies have been done to compare the wound outcome in preventing SSI between negative suction drain and no drain in which negative drain is superior but very few studies are there which compares 2 different types of drainage system in managing midline wounds.

This thesis proposal aims to compare the wound outcome between the use of negative suction and corrugated rubber drain in subcutaneous negative pressure drainage. The choice of drain type may significantly impact wound healing, but limited research exists on the direct comparison of negative suction and corrugated rubber drains in the subcutaneous plane. This study seeks to bridge this knowledge gap by evaluating wound outcomes associated with these two drainage techniques.

Therefore, a comparative analysis between ‘negative suction drain’ vs ‘corrugated rubber drain’ in the subcutaneous plane for postoperative stay and other postoperative complications is essential for the wound outcome.

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 99.00 Year(s)(—)
性别
All

入选标准

  • Perforation peritonitis >18 years of age Consent given.

排除标准

  • Midline laparotomy for other conditions, less than 18 years of age, Previous history of laparotomy, Patients with laparostomy, Undergoing re-exploration with in 15 days of surgery.

结局指标

主要结局

To compare Seroma formation, Hematoma and superficial wound dehiscence and need for intervention in both the study groups.

时间窗: 4 weeks after operative day

次要结局

  • To compare Duration of antibiotic use & hospital stay

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mona Aggarwal

All India Institute of Medical sciences, Raipur

研究点 (1)

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