PROPEL-2 Prophylactic Negative Pressure Wound Therapy (NPWT) in Laparotomy Wounds: a Randomised Controlled Trial Comparing Negative Pressure Wound Therapy to Standard Wound Management in Patients Following Midline Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 16
- 主要终点
- Rate of Surgical Site Infection (SSI)
研究概览
简要总结
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
详细描述
NPWT dressings are designed to remove and absorb any fluid leaking from the wound. This might reduce surgical site infections, improve wound healing and improve scar appearance compared to using standard dressings.
Data is limited in the application of NPWT dressings to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.
In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc., surgical site complications continue to represent a huge healthcare burden.
The Investigators are conducting this study to determine whether NPWT dressings reduce surgical site infections, improve wound healing and scar appearance. This study will also involve a cost-based analysis and seek information from patients on their quality of life. Results from this study will provide evidence on whether these dressings should be used as standard of care for management of surgical laparotomy wounds.
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
- 否
入选标准
- •Aged 18 years or older
- •Patient requires visceral abdominal surgery via a midline laparotomy
- •Patients who can complete questionnaires
排除标准
- •Patients who are unable to adhere to protocol requirements
研究组 & 干预措施
Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy.
干预措施: Negative Pressure Wound Therapy (Device)
Standard Wound dressing
After the skin is closed, the wound is covered using sterile standard gauze dressing.
干预措施: Standard wound dressing (Other)
结局指标
主要结局
Rate of Surgical Site Infection (SSI)
时间窗: 6 months following surgery
To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
次要结局
- Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings(6 months)
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)(6 months following surgery)
- Healthcare incremental cost- utility ratio(6 months)
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)(6 months following surgery)
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)(6 months)
- Healthcare cost-effectiveness ratio at 6 months(6 months)