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临床试验/NCT04832529
NCT04832529已完成不适用

A Perianal Abscess Cavity Packing Versus no Packing; a Randomized Control Trial.

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Post-operative pain

研究概览

简要总结

This prospective randomized trial will be conducted in all patients undergoing packing or no packing for perianal abscess cavity after incision and drainage, for 6 months after approval from IRB in Surgical unit III, Civil Hospital Karachi. Patient will be selected simple random sampling technique based on inclusion criteria. Patient will be assessed for post-operative pain, healing of cavity and recurrence of abscess. At first time of debridement pus or tissue will be sent for culture and sensitivity, meanwhile broad-spectrum antibiotic will be started.

Questionnaire will be filled by PI for post-operative pain, recurrence of abscess, quality of life, wound healing, post operative fistula in ano and chronic post surgical pain either due to packing or no packing.

详细描述

This is an experimental randomized control trial will start 6 months after approval from Institution Review Board. All patients with perianal abscess after incision and drainage cavity will be either packed or not after informed consent. Pack will be changed daily as regular dressing till healing occurs. Packing reduces bleeding and heals cavity by effect of dressing solution in which gauze is soaked. Other group with dressing will be changed daily and will be assessed for healing week. There is no pain in simple dressing applied over cavity. Patient will receive broad spectrum antibiotics according to pus or tissue culture. During this period, laboratory investigation CBC, CRP will be sent to check the response. Sits bath will be advised to both groups. Post-operative pain, cavity healing will be assessed by faculty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years
  • Age less than 70 years
  • Perianal abscess

排除标准

  • Suspected inflammatory bowel disease
  • Fournier's gangrene
  • Horseshoe/bilateral abscess

结局指标

主要结局

Post-operative pain

时间窗: 14 days

Pain will be assessed via visual analogue scale from 1-10 while changing of dressing.

次要结局

  • Decreases hospital visit(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lajpat Rai

Principal Investigator

Dow University of Health Sciences

研究点 (2)

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