Comparison of Wound Infection in Patients Undergoing Primary Closure and Open Technique in The Treatment of Pilonidal Sinus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Wound Infection
研究概览
简要总结
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.
详细描述
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.
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
- Single (Participant)
盲法说明
Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male &Female
- •Age between (18-75) Years
- •Patients with pilonidal sinus as defined in the operational definition.
排除标准
- •Patients with debilitating disease
- •Patients with immunocompromised state like malignancy, and tuberculosis.
研究组 & 干预措施
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.
干预措施: Primary Closure Technique (Procedure)
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.
干预措施: Open Technique (Procedure)
结局指标
主要结局
Wound Infection
时间窗: From surgery to 30 days post-operation
Frequency of wound infection within 30 days post-surgery
次要结局
- Wound healing time(From date of Surgery until 90 days.)
- Surgery time(During surgical procedure.)
研究者
Yousaf Jan
Principal Investigator
Hayatabad Medical Complex