Comparison of Primary Closure Vs Open Wound in Pilonidal Sinus Excision.
Comparison of Wound Infection in Patients Undergoing Primary Closure and Open Technique in The Treatment of Pilonidal Sinus.
The goal of this randomized clinical trial is to compare wound infection rates after two surgical techniques for treating pilonidal sinus in adults.
The main question this study aims to answer is:
Is wound infection less common after primary closure than after the open technique? Researchers will compare patients who receive primary closure with patients who receive the open technique after removal of the pilonidal sinus. The study will include 68 men and women between 18 and 75 years of age. Participants will be randomly assigned to one of the two treatment groups.
Participants will:
Undergo surgery using either primary closure or the open technique. Attend follow-up visits after surgery. Have the surgical wound examined 7 days after the procedure. Provide information about their health, medical history, and recovery. The study will record whether participants develop wound infection, including swelling, redness, or pus or clear fluid coming from the wound. The study will be conducted in the General Surgery Department at Medical Institute Haytabad Medical Complex, Peshawar.
研究概览
详细说明
Detailed Description
Pilonidal sinus is a chronic condition involving the skin and subcutaneous tissue in the sacrococcygeal or natal cleft region. It commonly presents with one or more midline openings, local pain, redness, swelling, or discharge. Surgical treatment is frequently required for symptomatic disease. However, the most appropriate method of wound management after excision remains uncertain. Primary closure may allow faster wound healing and reduce the period of open wound care, whereas the open technique may reduce tension on the wound but requires healing by secondary intention and regular dressing care.
This randomized controlled trial will compare two surgical approaches for the treatment of pilonidal sinus: primary closure and open healing. The study will be conducted in the General Surgery Department of Hayatabad Medical COmplex, Peshawar, after approval from the relevant institutional ethical review board and the research department of the College of Physicians and Surgeons Pakistan, Karachi.
Eligible participants who provide written informed consent will be assigned to one of two treatment groups using blocked randomization:
Group A: Excision of the pilonidal sinus followed by primary closure. Group B: Excision of the pilonidal sinus followed by open wound management and healing by secondary intention.
Before surgery, the research team will record relevant demographic and clinical information. Participants will undergo a clinical examination and routine preoperative assessment according to institutional practice. The surgical procedures will be performed under appropriate anesthesia by, or under the supervision of, a qualified general surgeon.
For participants in Group A, the sinus and surrounding diseased tissue will be excised down to the level of the sacral fascia. Any secondary tracts identified during surgery will also be removed. After achieving hemostasis, the wound will be closed in layers using polypropylene sutures. The closure will include approximation of the deeper tissues and skin. A suction drain may be placed when clinically indicated. The wound will then be covered with an appropriate sterile dressing.
For participants in Group B, the sinus and surrounding diseased tissue will be excised down to the sacral fascia. After hemostasis, the resulting cavity will be packed with povidone-iodine-soaked gauze. The initial packing will be removed approximately 48 hours after surgery. The wound will then remain open and will be managed with regular dressings until healing is complete. Participants in this group will attend outpatient follow-up visits, generally on a weekly basis or as clinically required.
Participants in both groups will receive postoperative care according to the hospital's standard practice. This may include analgesics, wound-care instructions, advice regarding hygiene, and instructions to return to the hospital if they develop worsening pain, fever, swelling, redness, or discharge. Follow-up assessment will be performed by the research team under the supervision of a consultant surgeon.
Information collected during the study will be recorded on a structured data-collection proforma. Each participant will be assigned a study identification number. Personal information will be kept confidential and will be accessed only by authorized members of the research team. The study findings will be analyzed to compare the postoperative wound outcomes of the two surgical techniques.
The study is intended to provide local clinical evidence regarding the choice between primary closure and open wound management after pilonidal sinus excision. The findings may help surgeons and healthcare professionals make evidence-based decisions about postoperative management and patient counseling.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
KPK
-
Peshawar、KPK、巴基斯坦、25000
- Hayatabad Medical Complex, Peshawar
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
INCLUSION CRITERIA:
- Male &Female
- Age between (18-75) Years
- Patients with pilonidal sinus as defined in the operational definition.
EXCLUSION CRITERIA:
- Patients with debilitating disease
- Patients with immunocompromised state like malignancy, and tuberculosis.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Primary Closure Technique
Patients undergo excision of the pilonidal sinus and surrounding tissue down to the sacral fascia, followed by closure with polypropylene sutures.
A suction drain (Radivac system) is placed, and vertical mattress sutures are used to approximate skin and subcutaneous tissue.
|
Excision of sinus tract with closure using Prolene sutures and placement of suction drain.
其他名称:
|
|
有源比较器:Open Technique
Patients undergo excision of the pilonidal sinus with surrounding tissue down to sacral fascia.
The wound is left open and packed with pyodine-soaked gauze.
Patients return for weekly outpatient follow-up until complete healing.
|
Excision of sinus tract with open wound packing and secondary healing.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound Infection
大体时间:From surgery to 30 days post-operation
|
Frequency of wound infection within 30 days post-surgery
|
From surgery to 30 days post-operation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound healing time
大体时间:From date of Surgery until 90 days.
|
Healing assessed weekly until closure.
|
From date of Surgery until 90 days.
|
|
Surgery time
大体时间:During surgical procedure.
|
Duration of intervention recorded in minutes.
|
During surgical procedure.
|
合作者和调查者
出版物和有用的链接
一般刊物
- Jabbar MS, Bhutta MM, Puri N. Comparison between primary closure with Limberg Flap versus open procedure in treatment of pilonidal sinus, in terms of frequency of post-operative wound infection. Pak J Med Sci. 2018 Jan-Feb;34(1):49-53. doi: 10.12669/pjms.341.13929.
- Kober MM, Alapati U, Khachemoune A. Treatment options for pilonidal sinus. Cutis. 2018 Oct;102(4):E23-E29.
- Iesalnieks I, Ommer A. The Management of Pilonidal Sinus. Dtsch Arztebl Int. 2019 Jan 7;116(1-2):12-21. doi: 10.3238/arztebl.2019.0012.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- RMI_QAD_RCT_PILONOIDAL_sINUS
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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