A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bates-Jensen Wound Assessment Tool (BWAT) score
研究概览
简要总结
To examine the effects of Physical Therapist (PT) wound care modalities (pulsed wound irrigation (PWI) + electrical stimulation (ES), PWI only, and ES only) on wound healing in patients with spinal cord injuries (SCI).
详细描述
It is hypothesized that PWI + ES will demonstrate the greatest rate of wound healing due to the combined effect of these treatments, which positively impact several aspects of the wound healing cascade. It is hypothesized that all patients will demonstrate improved quality of life from receiving wound care treatments by Physical Therapists due to individualized education and treatments which engage patients in their wound healing process and promote self-efficacy.
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
- •Currently enrolled at inpatient rehabilitation at Carolinas Rehabilitation Charlotte
- •Diagnosis of spinal cord injury and concomitant pressure injury to sacrum or ischium
- •Agreeable to wound care treatment by Physical Therapist (PT)
- •Able to perform informed consent
- •Over 18 years of age
- •Physician order for PT wound care evaluation and treatment
- •Bates-Jensen Wound Assessment Tool (BWAT) >31 on initial evaluation
排除标准
- •Pain which limits ability to tolerate wound care treatments
- •Unable to perform informed consent
- •Pregnancy
- •Bates-Jensen Wound Assessment Tool (BWAT) <30 on initial evaluation
研究组 & 干预措施
pulsed wound irrigation (PWI)
The necrotic wound is irrigated with normal saline (0.9%) with an 8-12 pounds per square inch pressure (PSI) to provide a mechanical force to loosen necrotic tissue for wound healing
干预措施: pulsed wound irrigation (PWI) (Procedure)
electrical stimulation (ES)
ES works to promote the migration of cells based on natural cell polarity known as galvanotaxis, enhancing and mimicking the natural current of injury. By recreating the natural electrical fields of the skin, ES attracts immune cells vital to healing to wound to facilitate wound closure
干预措施: electrical stimulation (ES) (Procedure)
electrical stimulation (ES) and pulsed wound irrigation (PWI)
The necrotic wound is irrigated with normal saline (0.9%) with an 8-12 pounds per square inch pressure (PSI) to provide a mechanical force to loosen necrotic tissue for wound healing and ES to promote the migration of cells based on natural cell polarity known as galvanotaxis, enhancing and mimicking the natural current of injury. By recreating the natural electrical fields of the skin, ES attracts immune cells vital to healing to wound to facilitate wound closure
干预措施: electrical stimulation (ES) and pulsed wound irrigation (PWI) (Procedure)
结局指标
主要结局
Bates-Jensen Wound Assessment Tool (BWAT) score
时间窗: Year 1
15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing
Bates-Jensen Wound Assessment Tool (BWAT) score
时间窗: Baseline
15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing
Bates-Jensen Wound Assessment Tool (BWAT) score
时间窗: Week 1
15-item objective measure designed to assess wound status and track healing - related to healing on a 1 (healed) to 5 (severe) scale to create a summative score between 13-65 with lower scores indicating progression towards healing
次要结局
- Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score(Baseline and Year 1)