Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
- Conditions
- Spinal Cord InjuriesPressure Injuries
- Interventions
- Procedure: pulsed wound irrigation (PWI)Procedure: electrical stimulation (ES)Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)
- Registration Number
- NCT05458947
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pulsed wound irrigation (PWI) 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 electrical stimulation (ES) 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 electrical stimulation (ES) and pulsed wound irrigation (PWI) 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
- Primary Outcome Measures
Name Time Method Bates-Jensen Wound Assessment Tool (BWAT) score 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
- Secondary Outcome Measures
Name Time Method Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score Baseline and Year 1 measures health-related quality of life specific to patients with Spinal Cord Injuries (SCI) - Higher scores indicate worse functioning quality of life related to pressure injuries, while lower scores indicate fewer impairments
Trial Locations
- Locations (1)
Carolinas Rehabilitation
🇺🇸Charlotte, North Carolina, United States