NCT02272881撤回不适用
The Santa Barbara Pressure Ulcer Study Comparison of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers: a Randomized, Prospective Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Wound Closure
研究概览
简要总结
The purpose of this study is to compare the number of and degree of pressure ulcers healed, as measured by intact skin at the original ulcer site at 6 months of follow-up in patients randomized to immediate operative closure versus those who are maintained in a wound care program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.
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
- •At least 18 years old;
- •Stage III or IV pressure ulcers on or near trochanter, ischium, sacrum or buttocks;
- •Receiving treatment at the Center for Wound Management - Goleta Valley Cottage Hospital; Santa Barbara Cottage Hospital or Santa Ynez Cottage Hospital, all part of Cottage Health System;
- •Underlying etiology for immobility secondary to spinal cord injury (SCI) or other neuromuscular condition not expected to become progressive in next 12 months;
- •No contraindications to undergo surgical intervention, including medical ability to tolerate surgical procedure with general anesthesia.
排除标准
- •Unable or unwilling to provide informed consent;
- •Underlying cause of immobility secondary to chronic medical disease outside of nonprogressive SCI or neuromuscular disease as described above;
- •Patients requiring immediate surgical closure determined by physician judgment;
- •Those deemed inappropriate to consider for surgery outside of study; potential reasons normally include medical comorbidities, inability to comply with post-operative care, and lack of funding source for elective procedure, peri-operative, and / or wound care.
- •Patients who have already been receiving active, professionally supervised wound care for > 2 week period prior to presentation
- •Patient is pregnant or breastfeeding.
研究组 & 干预措施
immediate surgical intervention
Experimental
immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure
干预措施: surgical reconstruction (Procedure)
wound care
Other
conservative wound management directed by certified wound care experts
干预措施: wound management (Procedure)
结局指标
主要结局
Wound Closure
时间窗: 6 months after randomization
measured by intact skin at the original ulcer site
次要结局
未报告次要终点
研究者
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