NCT03431220撤回不适用
A Prospective, Non-Comparative, Open, Multi-Center Study to Assess the Use of a New Negative Pressure Wound Therapy (NPWT) System (RENASYS Touch and RENASYS AB) in Temporary Abdominal Closure (TAC) For the Management of the Open Abdomen
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the number of days taken to achieve delayed primary fascial closure.
研究概览
简要总结
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
- •Subjects must be at least eighteen (18) yeaTS of age, or older.
- •Males and non-pregnant females.
- •Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).
排除标准
- •Grade 3 and Grade 4 open abdomens.
- •Malignancy in the reference wound bed or margins of the wound.
- •Patients with non-enteric unexplored fistulas.
- •High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
- •Pre-existing large ventral hernia.
- •Significant loss of abdominal wall fascia as a result of trauma or infection.
- •Patients with a known hist01y of poor compliance with medical treatment.
- •Patients who have participated in this trial previously and who were withdrawn.
研究组 & 干预措施
RENASYS TOUCH NPWT System
Experimental
Negative Pressure Wound Therapy (NPWT)
干预措施: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device (Device)
结局指标
主要结局
To determine the number of days taken to achieve delayed primary fascial closure.
时间窗: 14 days
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
次要结局
- To monitor the number and type of re-operations throughout the course of the study(14 days)
- To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)(14 days)
- To confirm the performance of the NPWT system in terms of: management of peritoneal fluid(14 days)
- To confirm the performance of the NPWT system in terms of prevention of infection(14 days)
- To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain(14 days)
- To assess the number of days to achieve final closure of the open abdomen(14 days)
- To confirm the performance of the NPWT system in terms of reduction in edema(14 days)
- To confirm the performance of the NPWT system in terms of prevention of fixity(14 days)
- To determine the type (method) of final closure of the open abdomen(14 days)
- To monitor the length of stay (days) in ICU and length of stay in hospital(14 days)
- To assess the number of dressing changes(14 days)
- To record clinicians' overall opinion on the usability of the new device throughout the study(14 days)
研究者
研究点 (1)
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