Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 82
- 主要终点
- Surgical Site Infection
研究概览
简要总结
Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e. polypropylene (Prolene) sutures or the skin staple sutures. The literature is very scarce on knee arthroplasty patients and the results of the studies conducted have been inconclusive of the studies conducted on the patients of knee arthroplasty. Moreover, there are no standard guidelines as to which type of suture should be used. The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure. Prolene sutures are made up of a synthetic steroisomer known as polypropylene. It is a monofilament non-absorbable, sterile surgical suture. They are indicated for use in general soft tissue. It Provides permanent tensile strength retention in tissue, even in the presence of infection. These sutures are exceptionally smooth for an easy passage through the tissue. Prolene sutures are widely used in cardiovascular, orthopedics, ophthalmic, and neurological surgical procedures. Another type of sutures that are used to close the surgical wound are the staple sutures. They are used as an alternative to the traditional Prolene sutures. They are non-absorbable and usually used on surgical wounds that are big, complex or hard to close by using Prolene. These are specialized staples made up of titanium, stainless steel or plastic.
Interventions:
The study will have 2 intervention arms. The patients will be randomized to receive either Prolene sutures for wound closure or staple sutures for wound closure. After the application of the intervention, routine care would be given to the patients postoperatively.
Hypothesis:
The investigators hypothesize that there is no difference in the incidence of surgical site infection in bilateral TKR patients with wound closure by Prolene vs staple.
Study Design:
This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be randomized to receive either of the two interventions i.e. Prolene or Staple sutures.
详细描述
Study Enrollment Procedures:
Enrollment will be a continuous process with screening and enrolling eligible patients admitted through the clinic electively for primary TKR. Informed consent will be taken from the patient as per routine protocol before the arthroplasty procedures in the hospital. Research objectives, methodology, risks, and benefits will be explained in detail. Consent for the participation in the study will only be taken by the primary investigator at his clinic or the surgical resident on call preoperatively along with the consent for the surgical procedure.
Pre-Randomization Evaluations Screening:
The screening will involve the routine history taking and physical examination by the doctor and nursing staff in the clinic. Screening won't involve performing procedures that are not part of routine management.
On-study/on-intervention evaluations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of age 40-70 years
- •Undergoing bilateral knee arthroplasty at AKUH Karachi.
- •Both the genders would be included.
- •Patients having American Society of Anesthesiologists (ASA) level of I, II and III
- •Patients having functional class of I, II and III pre-operatively
- •Patients opting to undergo Bilateral knee arthroplasty under care of the selected surgeon (A) for the study.
- •Patients undergoing bilateral TKR electively
排除标准
- •Patients unwilling to consent.
- •Patients unable to comprehend due to the language barrier
- •Patients who have a Glasgow Coma Scale i.e. GCS<15 (cognitive impairment)
- •Patients undergoing a knee revision surgery
- •Patients having a previous incision/scar in the operative field will be excluded
- •Patients having documented allergy to Prolene or stainless steel
- •Patients having a documented underlying malignancy
- •Patients undergoing unilateral TKR or staged bilateral TKR
- •Patients undergoing emergency TKR.
- •Patients having undergoing surgery due to trauma or fracture
结局指标
主要结局
Surgical Site Infection
时间窗: 6 weeks for superficial infections and 1 year for deep infections
Primary outcome of the study is the incidence of surgical site infection (superficial or deep) within 6 weeks for superficial infections and 1 year for deep infections.
次要结局
- Pain Score(post-operative follow up at 14th post-op day)
- Post Operative complications(Within 2 weeks of surgery)
研究者
Ahsun Jiwani
Junior Biostatistician
Indus Hospital and Health Network
