PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Wound closure without surgical revision at Day 42
研究概览
简要总结
The investigators compare negative pressure wound therapy (NPWT) using the PICO 7 system versus professional wound debridement alone in adult orthopedic patients with acute, non-infected wound dehiscence or diabetic foot ulcers. Patients are randomized 1:1 to either PICO therapy (minimum 7 days, up to 42 days) or standard wound care (professional debridement without NPWT). The primary outcome is wound closure without surgical revision at Day 42. The trial is stratified for diabetic foot ulcers to enable subgroup analysis.
详细描述
Acute postoperative wound dehiscence and foot ulcers represent a frequent clinical challenge in adult orthopedic patients worldwide. According to institutional data, wound dehiscence occurs in 2-5% of elective orthopedic procedures, depending on surgery type, patient comorbidities, and obesity. Among patients with diabetes, approximately half will develop foot ulcers during their lifetime.
The management of non-infected wounds can be either surgical (revision surgery with primary closure) or conservative (professional debridement and wound care with or without negative pressure wound therapy). Despite widespread clinical experience with NPWT in orthopedic surgery, high-quality prospective evidence remains scarce. The orthopedic literature lacks adequately powered randomized controlled trials comparing NPWT to standard wound care for acute, non-infected wound dehiscence.
The investigators hypothesize that NPWT leads to superior wound closure rates (85% vs. 70%) and accelerated healing compared to professional debridement alone. The PICO Single Use Negative Pressure Wound Therapy System creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting secondary closure through controlled suction at -80 mmHg.
The BALPIC trial evaluates a therapeutic concept rather than comparing different NPWT devices. Infected wounds are excluded, as NPWT is conventionally avoided over purulent wounds to allow free drainage. Wound assessment is performed by specialized wound nurses using standardized measurements and photographic documentation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age ≥ 18 years
- •Able to consent
- •Patient of orthopaedic surgery or of the (Diabetic) Foot Polyclinic at the Balgrist University Hospital
- •Presence of an acute, dehiscent, clinically uninfected wound requiring additional measures
- •First episode of wound treatment for the actual wound (no recurrences) in the last 12 months
- •Wound measuring ≥ 0.5 cm in wide, length or depth
- •42 days of scheduled follow-up
- •Bacterial orthopaedic infections of any nature, independently of implants or co-morbidities; according to clinical, laboratory, radiological, microbiological features of infection
- •First or second episode of infection
排除标准
- •- Patient's individual refusal to participate
- •Patient already treated with any vacuum-assisted wound device for any wound in the last 12 months; independently of therapy success, the hospital or the localization of the prior wound
- •Underlying liquor leak (spine surgery)
- •Visually active bleeding from the wound
- •Wound size >10 cm in any dimension
- •Anticipated active clinical follow-up of less than 42 days
- •Other wound treatments besides PICO and debridement (e.g. hyperbaric oxygen therapy, other negative-pressure devices, local antibiotics, local antibiotic dressings) (however, local antiseptics and dressing changes remain allowed)
- •Immediate surgical wound revision in the operating theatre for closure
- •Planned plastic or reconstructive surgery already at inclusion
研究组 & 干预措施
PICO
Application of PICO 7 Single Use NPWT System at -80 mmHg for a minimum of 7 days. PICO therapy may be continued for up to 42 days based on clinical necessity. Device change every 7 days. Wound assessment weekly. SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP (UDI 04582111156419). The PICO system creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting wound closure through controlled suction.
干预措施: Professional Wound Care (Procedure)
Professional Wound CAre
Professional wound debridement by specialized wound nurses, including dressing changes and local antiseptics if clinically indicated, without the use of any negative pressure device. Treatment for up to 42 days based on clinical necessity. Wound assessment weekly. Individualized professional wound care according to hospital and Swiss nursing guidelines. The intensity of debridement, dressing type, and antiseptic use lies at the discretion of the wound nurse and will be recorded.
干预措施: Professional Wound Care (Procedure)
结局指标
主要结局
Wound closure without surgical revision at Day 42
时间窗: Day 42 (±7 days)
Wound closure is defined as reduction of wound size by a minimum of 90% compared to baseline, without need for surgical revision. Wound failure is defined as persistent wound (less than 90% reduction) after 42 days or surgical wound revision during the study period.
次要结局
- 2. Rapidity of wound closure(Day 7, 14, 21, 28, 35, and 42)
- Wound closure without surgical revision at Day 7, 14, 21, 28, and 35(Day 7, 14, 21, 28, and 35 (±2 days))
- 4. Wound closure for diabetic foot ulcers only (stratified analysis)(Day 42 (±7 days))
- 5. Adverse events related to wound therapy(Day 1 to Day 42 (±7 days))
- 6. Length of hospital stay(Day 1 to Day 42 (±7 days))
- 7. Overall costs of hospitalization(Day 1 to Day 42 (±7 days))
研究者
Ilker Uckay
Prof. Dr. med. Ilker Uçkay
Balgrist University Hospital