Evaluation of Platelet Rich Plasma in Reducing Sternal Wound Complications in CABG Surgery With Median Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Superficial & Deep Sternal Wound Infections, Delayed Wound Healing and readmission.
研究概览
简要总结
The goal of this clinical trial is to learn whether applying autologous platelet-rich plasma (PRP) to the sternal wound during heart surgery improves wound healing and reduces complications after surgery. The study also aims to evaluate whether PRP can reduce hospital-related outcomes and costs.
The main questions this study aims to answer are:
Does the use of PRP reduce superficial & deep sternal wound infections and rate of readmissions?
Does PRP improve wound healing after heart surgery?
Does PRP reduce the cost of hospitalization and length of ICU stay.
Does PRP reduce the requirement of red cell concentrate (RCC) and platelets to less than 4 units each
Researchers will compare PRP applied to the sternal wound before closure with standard sternal wound closure alone to determine whether PRP provides additional benefit beyond standard surgical care.
Participants were randomly assigned to one of two groups.
Participants will:
Receive standard sternal wound closure or PRP applied to the sternal wound followed by standard closure
Be monitored for wound infections and healing outcomes after surgery
Have hospital cost, RCC & platelet units used, ICU stay, and readmission data recorded during the postoperative period
Patients and outcome assessors were blinded to the treatment assignment. Surgeons were aware of the intervention due to the nature of the procedure.
This study aims to determine whether adding PRP to standard sternal closure can improve recovery and reduce complications following cardiac surgery.
详细描述
Official Title:
Evaluation of Platelet Rich Plasma in Reducing Sternal Wound Complications in CABG Surgery With Median Sternotomy.
Study Background:
Median sternotomy is the standard approach for most cardiac surgeries, providing low failure rates and good long-term outcomes. However, complications such as wound infection, sternal dehiscence, and delayed healing, although uncommon, can lead to serious morbidity, longer hospital stays, and increased costs. Risk factors include obesity, diabetes, smoking, steroid use, osteoporosis, chronic lung disease, and mobilization of the internal mammary arteries. Platelet-rich plasma (PRP), which contains concentrated platelets and growth factors, has shown promise in promoting tissue healing, reducing infections, and supporting bone regeneration. PRP is used in various surgical fields but is not yet routine in cardiac surgery. Early studies suggest that applying PRP during sternotomy may reduce postoperative sternal wound complications and the need for reoperation.
Rationale:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are blinded to group assignment. Surgeons performing the procedure and the study investigator are aware of the intervention to ensure proper delivery of PRP and adherence to the study protocol.
入排标准
- 年龄范围
- 45 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 45 to 72 years,
- •undergoing median sternotomy for CABG surgery.
- •Able and willing to provide informed consent.
排除标准
- •Known Diabetics,
- •Patients unable or ineligible to donate blood for standard blood bank procedures, which includes those with low hemoglobin, blood disorders, infections, or other medical conditions preventing safe blood collection
- •Patients from whom autologous platelet-rich plasma (PRP) cannot be obtained due to low platelet counts, blood disorders, or other technical/medical reasons
- •Cardiopulmonary bypass (CPB) time > 72.5 minutes
- •Bilateral internal mammary artery harvested
- •Body Mass Index (BMI) < 18.5 or > 24.9
- •Active smokers
- •Chronic lung disease
- •Osteoporosis
- •Current steroid therapy
研究组 & 干预措施
Standard Sternal Wound Closure
Conventional sternal wound closure is performed without platelet-rich plasma. Participants and outcome assessors are blinded to group assignment; surgeons are aware of the intervention. Postoperative outcomes including superficial and deep sternal wound infections, delayed wound healing, cost (pre-specified secondary outcome), rate of admissions, and other observed outcomes such as length of hospital stay and more than 4 units of RCC & platelets were assessed.
干预措施: Standard Sternal Wound Closure (Procedure)
PRP with Standard Sternal Wound Closure
Autologous platelet-rich plasma (6 ml) is applied to the sternal wound before closure. Participants and outcome assessors are blinded to group assignment; surgeons are aware of the intervention. Postoperative outcomes including superficial and deep sternal wound infections, delayed wound healing, cost (pre-specified secondary outcome), rate of admissions, and other observed outcomes such as length of hospital stay and more than 4 units of RCC & platelets were assessed.
干预措施: Autologous Platelet-Rich Plasma (PRP) Application (Procedure)
结局指标
主要结局
Superficial & Deep Sternal Wound Infections, Delayed Wound Healing and readmission.
时间窗: Up to 30 days postoperatively
Superficial Sternal Wound Infection (Defined as infection limited to skin and subcutaneous tissue within 30 postoperative days, not involving the sternum, requiring local wound care and antibiotic therapy or Vacuum Assisted Closure VAC therapy. Unit of Measure: Number of participants) Deep Sternal Wound Infection (Diagnosis will be made in patients developing one or more of the following within 30 postoperative days: positive culture of mediastinal tissue or fluid; clinical evidence of mediastinitis during sternal reoperation; or chest pain, sternal instability or purulent mediastinal discharge associated with a positive blood culture. Unit of Measure: Number of participants) Delayed Healing (Defined as failure of skin, subcutaneous tissue, or sternum to heal within 14 days after surgery. Unit of Measure: Number of participants) Readmission (Defined as any hospital readmission within 30 days of discharge related to the index surgery. Unit of Measure: Number of participants)
次要结局
- Cost of hospitalization(From surgery to hospital discharge, up to 30 days postoperatively)
研究者
Sangeen khan Wazir
Registrar, Cardiac Surgery
Shaheed Zulfiqar Ali Bhutto Medical University