ISRCTN26277546已完成未知
A pragmatic, multicentre, randomised controlled trial to assess the clinical and cost effectiveness of negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI 2)
Hull University Teaching Hospital NHS Trust0 个研究点目标入组 686 人开始时间: 2019年3月25日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 686
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34696784/ (added 19/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 16 years or over
- •2. Has an acute SWHSI (i.e. a wound left open as planned following surgery or a wound initially closed using sutures, clips, or other closure methods and dehisced along the whole or part of its length, and of less than 6 weeks in duration), arising from any surgical specialty and occurring on any part of the body, deemed appropriate to receive either NPWT or wound dressing treatment
- •3. Has a SWHSI that is considered ready for NPWT treatment (i.e. contains at least 80% viable tissue or has only a very thin layer of slough requiring no further debridement)
- •4. Patient is not deemed to be malnourished, as per NICE guidelines CG 32 (BMI <18.5 kg/m2; unplanned* weight loss >10% in the last 3-6 months; BMI <20kg/m2 and unplanned* weight loss >5% in the last 3-6 months) or assessed as at high risk of malnutrition using the Malnutrition Universal Screening Tool (MUST)
- •*Patients with weight loss arising either from underlying comorbidity (e.g. ulcerative colitis) or from the reasons for surgery being completed (e.g. bowel cancer) may be included at the clinician’s discretion
- •5. Willing and able to give informed consent and provide follow-up data
排除标准
- •Current participant exclusion criteria as of 01/04/2022:
- •1. Life expectancy of less than 6 months e.g. undergoing end stage palliative care
- •2. Active systemic infection (including osteomyelitis) at baseline as defined by clinical and/or laboratory assessment. Note: Patients who have an active infection, but are improving following 1 week’s duration of antibiotics may be included at the clinician’s discretion
- •3. Inadequate haemostasis or patients who are at risk of bleeding
- •4. Chronic wounds non-surgical in origin (e.g. pressure ulcers or foot ulcers)*
- •*Note diabetic foot ulcers which have been incised and drained or debrided as an inpatient in theatre may be included given this constitutes a surgical wound.
- •5. Current wound has previously been, or is currently being, treated with NPWT
- •6. Planned delayed primary closure of the wound
- •7. Contraindication to NPWT including: presence of unclear undermining in the wound cavity; presence of necrotic tissue, malignant tissue or eschar; wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the open abdomen” where the abdominal fascia is open); wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained; presence of a non-enteric or unexplored fistula; people requiring emergency airway aspiration, pleural mediastinal or chest tube drainage or surgical suction (removed 07/11/2019: people with a sensitivity or allergy to silver)
- •8. Currently participating in another wound research study, where the primary outcome time point has not yet been reached
- •Previous participant exclusion criteria:
- •1. Life expectancy of less than 6 months e.g. undergoing end stage palliative care
- •2. Active systemic infection (including osteomyelitis) at baseline as defined by clinical and/or laboratory assessment. Note: Patients who have an active infection, but are improving following 1 week’s duration of antibiotics may be included at the clinician’s discretion
- •3. Inadequate haemostasis or patients who are at risk of bleeding
- •4. Chronic wounds non-surgical in origin (e.g. pressure ulcers or foot ulcers)
- •5. Current wound has previously been, or is currently being, treated with NPWT
- •6. Planned delayed primary closure of the wound
- •7. Contraindication to NPWT including: presence of unclear undermining in the wound cavity; presence of necrotic tissue, malignant tissue or eschar; wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the open abdomen” where the abdominal fascia is open); wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained; presence of a non-enteric or unexplored fistula; people requiring emergency airway aspiration, pleural mediastinal or chest tube drainage or surgical suction (removed 07/11/2019: people with a sensitivity or allergy to silver)
- •8. Currently participating in another wound research study, where the primary outcome time point has not yet been reached
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