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临床试验/NCT07750093
NCT07750093进行中(未招募)不适用

Comparison Of Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Complications

研究概览

简要总结

The goal of this clinical trial is to compare the frequency of post-circumcision complications (bleeding, infection, and delayed ring separation) time for ring separation and level of parental satisfaction following local application of Polyfax versus coconut oil after Plastibell circumcision in infants in. Patient undergoing Plastibell circumcision will be divided into 2 groups, we will prescribe Polyfax to one group as a part of post circumcision care and coconut oil to the other group. Division into groups will be random using the lottery method, participant will visit the clinic at 1 week, 3 months and 6 months. A questionnaire will be filled by the doctor.

详细描述

Objective of study:

  • To compare the frequency of post-circumcision complications-such as bleeding, infection, and delayed ring separation-following local application of Polyfax versus coconut oil after Plastibell circumcision in infants (<6 months of age).
  • To compare the time for ring separation between the two treatment groups.
  • To compare the level of parental satisfaction following the use of Polyfax versus coconut oil

Methodology The patient who fulfill the inclusion criteria will be included in the study. Patient undergoing Plastibell circumcision will be divided into 2 groups, we will prescribe Polyfax to one group as a part of post circumcision care and coconut oil to the other group. Division into groups will be random using the lottery method. Half the envelopes will contain a card with polyfax on it and the other half will have coconut oil. A questionnaire will be filled by the doctor for all post circumcision patients undergoing plastibell circumcision whose guardians have given consent to be included in the study. Demographic details such as age and weight will be recorded from the patient file. All patients will undergo a standard Plastibell circumcision in the daycare theatre. An assistant will gently restrain the infant, after adequate exposure local anesthesia is given in form of a penile block. Diluted lidocain prepared according to weight of child is injected at base of phallus at 1 and 11 o clock. A dorsal slit is made in the foreskin and adhesions between foreskin and glans are removed. A Plastibell is then introduced between glans and prepuce and hemostatic ligature is tied around base of prepuce overlying a groove in Plastibell. Foreskin distal to ligature is excised. The surgical site is cleaned either polyfax or coconut oil is applied. The child will be redressed and returned to parents and detailed instructions will be provided to parents regarding the postoperative care and follow up verbally and in writing. Data regarding outcome will be gathered by interviewing the parents as well as through clinical examination in the OPD. Data will be entered and analyzed via SPSS. The effect modifiers and biasness will be controlled by strictly following the inclusion and exclusion criteria and use of lottery method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Week 至 6 Months(Child)
性别
Male
接受健康志愿者
否

入选标准

  • •All male patients undergoing Plastibell circumcision <6m of age, whose parents/ guardians have given consent

排除标准

  • •Patient with a known coagulation disorder
  • •Immunosuppressed patients
  • •Patients with a dermatologic condition
  • •Non-compliant patients

研究组 & 干预措施

Coconut oil group

Experimental

coconut oil used for local application

干预措施: agent used for local application (Other)

Polyfax

Experimental

Polyfax for local application

干预措施: agent used for local application (Other)

结局指标

主要结局

Complications

时间窗: 3 months

Post circumcision bleeding, infection, delayed ring seperation

次要结局

  • Parental satisfaction(3 month)

研究者

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

Saiyeda Mahin Fatima

Resident

Liaquat National Hospital & Medical College

研究点 (1)

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