Standard Wound Dressing Versus Prophylactic Negative-pressure Wound Therapy After Emergency Laparotomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 334
- 主要终点
- To determine if the use of prophylactic negative-pressure wound therapy (Prevena) reduces the incidence of superficial surgical site infection after emergency laparotomy in patients at high-risk for SSI
研究概览
简要总结
Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections.
Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.
详细描述
Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the most frequent wound occurrences are represented by wound infections, skin dehiscence or parietal hernias.
Despite standard surgical aseptically technique and perioperative prevention management of infections (e.g. antibiotics), wound complications after emergency laparotomies are still an important unmet challenge.
Moreover, all these complications increase the cost of care requiring new managements.
CINPt has been longly used to favour the successful healing of a plethora of open wounds.
In particular CINPt is based on the application of local negative pressure to the wound surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed central foam, which is placed on the surface of the viscera. Then, two layers of porous sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is placed over the foam and the wound to seal the abdominal cavity. The entire system is then connected, by suction tubes, to a device which ubiquitously applies negative pressure (cyclically or continuously) on the surface. The fluid from the wound is collected into a container. The benefits of negative pressure wound therapy have been reported to include removal of infectious material, reduction in oedema and improved perfusion to tissue. Since few years, a new negative pressure wound therapy has been created for closed wounds to reduce time of healing and avoid wound complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patient
- •≥10cm emergency median laparotomy
- •Abdominal wall and skin closure in first intent
- •Septic peritoneal cavity (purulent and/or fecaloid free liquid and/or abscess)
- •Informed written consent
排除标准
- •No abdominal wound closure in first intent
- •Allergy or hypersensitivity to silver
- •Application of a mesh for abdominal wall closure
- •Patients under corticosteroids or other immunosuppressive treatment.
- •Women who are pregnant or breast-feeding.
- •Intention to become pregnant during the course of the study.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- •Previous enrolment in the current study.
结局指标
主要结局
To determine if the use of prophylactic negative-pressure wound therapy (Prevena) reduces the incidence of superficial surgical site infection after emergency laparotomy in patients at high-risk for SSI
时间窗: up to 30 days post procedure
Any SSI may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Superficial site infection will be assessed by Wound Classification System Using the American College of Surgeons National Surgical Quality Improvement Program ACS-NSQIP : * Clean; these are uninfected operative wounds in which no inflammation. * Clean/contaminated; These are operative wounds in which the respiratory, alimentary, genital, or urinary tract is entered Under controlled conditions and without unusual contamination. * Contaminated; These include open, fresh, accidental wounds, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, non-purulent inflammation is encountered. * Dirty ; These include old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera.
次要结局
- 30-day Return to Operating Room (ROR)(30 days post procedure)
- Length of stay (LOS) in days.(30 days post procedure)
- Incidence rates of wound complications(30 days post procedure)
研究者
Abbassi Ziad
Principal investigator, M.D.
University Hospital, Geneva