Effects of Preventive Negative Pressure Wound Therapy With PICO on Surgical Wounds of Kidney Transplant Patients: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- post-kidney transplant wound complication rates
研究概览
简要总结
Advances in surgical techniques and immunosuppression (IS) have led to an appreciable reduction in postoperative complications following kidney transplantation. However, surgical site events (SSE) including surgical site infections (SSI) and other wound complications are still very common and they can limit these improved outcomes and result in prolonged hospitalization, hospital readmission and reoperation, consequently increasing overall transplant cost.
Negative pressure wound therapy (NPWT) is a concept introduced initially to assist in the treatment of chronic open wounds. This technique uses a negative pressure unit and specific dressings that help to hold the incision edges together, redistribute lateral tension, reduce edema, stimulate perfusion and protect the surgical site from external infectious sources. Thus, it provides faster wound healing and shortens hospital stay.
Recently, there has been growing interest in using portable NPWT devices on closed incisions after surgery to prevent potential SSI and other wound complications in high-risk patients. Investigations regarding this technique in various surgical settings have shown that it can reduce the risk of SSI and other wound complications. These studies concluded that any patient undergoing transplantation should be considered as 'high-risk' and should receive this treatment.
To date, no studies are reported in literature exploring the effects of preventive use of portable NPWT devices on surgical wounds in the setting of organ transplantation. The aim of our study is to compare a portable NPWT device (PICO, Smith & Nephew, London UK) to conventional gauze dressings in patients undergoing kidney transplantation (KT) surgery.
详细描述
Patients admitted to our transplant surgery inpatient floor for cadaveric kidney transplant surgery will be reviewed with the circle of care team and approached for consent if deemed suitable for this trial. A Nova Scotia Health Authority Research Ethics Board approved informed consent form will be utilized in the consent discussion and patients will be provided time to read the document in full before being asked for a decision on participation.
Patients who give their consent for the study will be randomized to 'PICO' or 'Control' group. The randomization process will be held during the time period between the admission of the patient to the inpatient floor and referral of the patient to the operating room. Randomization process will be conducted by the transplant fellow or the research associate who will randomly pick an envelope from a box full of 60 same-sized, same-colored and closed envelopes each time a patient gives consent. Among those 60 envelopes 30 will have the 'PICO' card inside, while the remaining 30 envelopes will have 'control' card. Assignment process will be completed when 30 consecutive patients are included in each group. There will be 1 control per case.
For both patient groups the surgical wound closure procedure will be the same: At the end of each cadaveric kidney transplant procedure the wound edges will be approximated by means of running subcuticular suture with non-absorbable stitches (3/0 polypropylene/polyethylene). For patients randomized to the 'PICO' group, PICO will be applied in the operating room immediately after closure and the continuous negative pressure set at -80 mmHg.
For patients randomized to the control group standard of care basic wound contact absorbent dressings will be applied in the operating room immediately after the closure of the surgical wound.
Follow-up care:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years of age)
- •female/male cadaveric kidney transplant recipients who have a preoperative order for standard induction immunosuppression protocol (basiliximab and methylprednisolone) and give written consent will be included in this study.
排除标准
- •Patients who have a pre-operative order for a non-standard induction immunosuppression regimen
- •Patients deemed not capable to take care for the PICO device
- •Multi-organ transplant recipients (simultaneous liver-kidney transplant, simultaneous kidney-pancreas transplant)
- •Dual KT recipients (simultaneous kidney-kidney transplant)
结局指标
主要结局
post-kidney transplant wound complication rates
时间窗: up to 12 months
Primary outcome of this study will be 'post- KT wound complication (superficial wound dehiscence, evisceration, seromas, incisional hernias, wound infections and wound necrosis) rates'. The potential relation of these complications with PICO application will be assessed.
次要结局
未报告次要终点