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临床试验/NCT07633977
NCT07633977已完成不适用

A Comparative Study of Wound Outcome and Patient Satisfaction Between Incisions Closed With Staples and Sutures Following Elective Upper Limb Orthopedic Surgeries

Kathmandu University School of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1

研究概览

简要总结

Surgical wound closure is an essential component of postoperative care that influences wound healing, infection rates, cosmetic appearance, and patient satisfaction. Sutures are conventionally used for skin closure following orthopedic procedures; however, surgical staples have gained popularity because of their rapid application, secure fixation, and potentially superior cosmetic outcomes. Despite their widespread use, there remains limited evidence comparing cosmetic outcomes and patient satisfaction between staple and suture techniques in upper limb surgeries in the local setting.

This study aims to compare the cosmetic outcome and patient satisfaction between staples and sutures for wound closure following upper limb surgeries at Dhulikhel Hospital. Secondary objectives include comparing wound infection rates and duration of hospital stay between the two techniques.

A prospective comparative study is conducted among adult patients undergoing upper limb surgeries. Patients fulfilling the inclusion and exclusion criteria are recruited consecutively during the study period. Following completion of surgery, wound closure is performed either with interrupted sutures or surgical staples according to the operative plan. Wounds are to be evaluated on postoperative day 2, day 7, and day 14, with further follow-up at 30 days and 6 weeks.

Cosmetic outcome and patient satisfaction are assessed using a 5-point Visual Analogue Scale (VAS). Pain assessment, wound complications including infection, and duration of hospital stay are also documented and compared between the two groups. The findings of this study can help identify the optimal skin closure method for upper limb surgeries and contribute to improved postoperative outcomes and patient satisfaction.

HYPOTHESES OF THE STUDY Null hypothesis (Ho): there is no difference in cosmetic outcome and patient satisfaction between sutures and staple technique for wound closure following upper limb surgeries.

Alternative hypothesis (H1): there is difference in cosmetic outcome and patient satisfaction between sutures and staple technique for wound closure following upper limb surgeries

Hence, Ho : (Cosmetic and Patient satisfaction score) in Suture group = Cosmetic and Patient satisfaction score) in Staples group H1 : (Cosmetic and Patient satisfaction score) in Suture group ≠ (Cosmetic and Patient satisfaction score) in Staples group

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Adult patient (> 18 years and above)
  • Any wound more than two centimeters in length
  • All closed fracture of upper limb requiring open reduction and internal fixations
  • All implant removal and benign tumor excision of upper limb

排除标准

  • Open upper limb fracture
  • Known metal allergy(nickel, titanium)
  • Active infection
  • Malignant tumor excision
  • Tendon repair
  • Closed Reduction Percutaneous Pinning

研究者

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

Rohit Shrestha

Professor

Kathmandu University School of Medical Sciences

研究点 (1)

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