A Prospective, Randomized, Controlled Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds (VACoCREW Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Early wound closure
研究概览
简要总结
There is a treatment method called negative-pressure wound therapy (NPWT) that is well established and used for the treatment of wounds. The method involves the application of a wound dressing through which a negative pressure is applied. Due to a plastic film overlaying the wound the risk of wound contamination is reduced. NPWT is considered to promote wound healing and prevent infection and has previously been used in the treatment of acute war associated wounds with satisfactory results. The aim of this study is to compare NPWT with conventional wound dressings in the treatment of war-associated extremity wounds and evaluate which method is more effective.
详细描述
Trial locations:
Médecins Sans Frontières/Doctors Without Borders (MSF) is one of the worlds leading independent organizations for medical humanitarian aid. MSF conducts an emergency trauma project in the Ministry of Health hospital in Ar Ramtha, Jordan, less than five kilometers from the border with Daraa governorate in Syria. A majority of patients within the project receive treatment for blast- and gunshot-related trauma wounds originating from the Syrian armed conflict. Within the project wound management has been difficult, often complicated by infection and antibiotic resistance. A need for wound therapy alternatives better than the conventional wound dressing method currently used has been identified.
Emergency hospital in Erbil, Iraq is a trauma hospital. Patients originate from armed conflicts in Mosul and the Iraqi Kurdistan region.
Background:
Extremity wounds and fractures constitute the majority of war-associated traumatic injuries, both for civilians (Aboutanos & Baker 1997) and combatants (Owens et al. 2007). Conflict-related injuries often result in soft and boney tissue being contaminated with foreign material, generally leading to secondary infection (Fares et al. 2013; Covey et al. 2000). Negative-pressure wound therapy (NPWT) is widely used in the treatment of wounds and is considered to promote wound healing and prevent infectious complications. The technique involves the application of a wound dressing through which a negative pressure is applied. Any wound and tissue fluid is drawn away from the area and collected into a canister. The risk of wound contamination is reduced by a plastic film overlaying the wound. NPWT is supported for use in a range of surgical applications, including after or in between debridements as a bridge to definite closure of soft tissue wounds (Krug et al. 2011). The technique has previously been used in the treatment of acute conflict-related wounds with satisfactory results (Machen 2006; Peck et al. 2007; Leininger et al. 2006).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age with extremity blast- or gunshot-wound(s). In case of multiple wounds the extremity wound with the estimated largest area is selected.
排除标准
- •Wounds presenting >72 hours following initial trauma.
- •Wounds that are considered ready for primary closure by suture or split-thickness skin graft.
研究组 & 干预措施
Negative-pressure wound therapy
Vaccum Assisted Closure device. Patients will receive negative-pressure wound therapy according to manufacturer treatment guidelines.
干预措施: Vaccum Assisted Closure device (Device)
Standard
Patients will be treated with conventional wound dressings according to local treatment protocols.
干预措施: Conventional wound dressings (Procedure)
结局指标
主要结局
Early wound closure
时间窗: Day five +-1
Wound closure, either by suture or split-thickness skin graft
Cost-effectiveness comparing outcomes from NPWT and standard treatment
时间窗: Days (between 1 and 50)
Costs from the health care provider's perspective will be used. Cost-effectiveness will be expressed in US dollars.
次要结局
- Rate of wound healing(Days (between 1 and 50))
- Wound infection(Days (between 1 and 50))
- Time until wound is deemed no longer requiring professional care(Days (between 1 and 50))
- Time to discharge(Days (between 1 and 50))
- Quality of life aspects(Days five and eight)
- Full wound healing at follow-up(Day 30 following wound closure)
- Septicaemia(Days (between 1 and 50))
- Mortality(Days (between 1 and 50))
- Wound size ratio day fourteen(Day 14)
- Number of surgeries(Days (between 1 and 50))
研究者
Jonas Malmstedt
MD, PhD
Karolinska Institutet