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临床试验/NCT06725472
NCT06725472已完成不适用

Comparison of the Classic Median Sternotomy Skin Incision with the Paramedian Flap Skin Incision Technique in Open Heart Surgery

Ataturk University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月21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
90
试验地点
1
主要终点
Determination of the effectiveness of paramedian flap skin incision technique.

研究概览

简要总结

The goal of this observational study is to determine the effects of a flap-shaped paramedian skin incision on protection from mediastinal infections, wound healing, and scar formation in open heart surgery performed through the classic median sternotomy approach compared with the classic median skin incision. The main question aimed to be answered is:

Is paramedian flap skin incision effective in improving sternotomy wound healing? Does it have a preventive effect on the development of sternal wound infection? Does it have a protective effect on keloid formation? Patients who underwent open-heart surgery with classical median sternotomy will be randomized into two groups: paramedian flap skin incision and median skin incision. The effectiveness of the paramedian incision will be investigated by comparing perioperative data and data from the first three months of follow-up.

详细描述

Median sternotomy (MS) is the classic opening technique for open heart surgery. The skin incision is made in line with the bone incision at the center of the sternum. The paramedian flap skin incision involves making a skin incision approximately 2-3 cm lateral to the sternal bone incision, then lifting the skin as a flap using subcutaneous tissue. The investigators aim to determine the efficacy of the paramedian flap skin incision by comparing it with the classic median skin incision, considering that this flap-style incision may result in faster wound healing and better protection against infections.

In a six-month period, 90 consecutive patients who underwent open heart surgery with classic median sternotomy in the Cardiovascular Surgery Clinic will be randomized into two groups: classic median skin incision and paramedian flap skin incision. The investigators will prospectively record data from 45 individuals in both groups and will follow them up at the first week, first month, and third month after discharge. During the follow-ups, physical examinations will be performed, wound sites and sternal bone healing processes will be evaluated, and infection status will be checked through radiologic and laboratory examinations.

Surgical Technique

Classic Median Sternotomy Skin Incision:

After the anesthesia procedures are completed in the supine position, under general anesthesia, following skin disinfection and sterile dressing, a longitudinal skin incision is made in the midline of the sternum from the jugulum to the xiphoid. Subcutaneous hemorrhages are cauterized, the periosteum is scratched in the midline with electrocautery, and a sternotomy is performed with a sternum saw, after which open heart surgery procedures are continued. In closure, after the sternum is closed, the subcutaneous tissue is first closed with the continuous suture technique, and then the skin is closed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective open heart surgery via median sternotomy.
  • Age range: Over 18 and under 80 years of age.

排除标准

  • Who do not accept informed consent,
  • Failure to show up for necessary check-ups,
  • Emergency surgery (not elective emergencies),
  • Patients with exitus in the hospital in the postoperative period and during the 3-month follow-up period.

结局指标

主要结局

Determination of the effectiveness of paramedian flap skin incision technique.

时间窗: 1 week, 3 month

Observation of wound epithelization and healing process.

次要结局

  • Surgical wound infection development(1 week, 3 month)

研究者

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

Eyüpserhat ÇALIK

Associate Professor

Ataturk University

研究点 (1)

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