Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury

Conditions
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Spinal Cord Injuries, Pressure Injuries

Intervention / Treatment
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* Procedure: pulsed wound irrigation (PWI)
* Procedure: electrical stimulation (ES)
* Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To examine the effects of PT wound care modalities (PWI + ES, PWI only, and ES only) on wound healing in patients with SCI
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pulsed wound irrigation (PWI)<br>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 | Procedure: pulsed wound irrigation (PWI)<br>* 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<br>|
| Experimental: electrical stimulation (ES)<br>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 | Procedure: electrical stimulation (ES)<br>* high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes<br>|
| Experimental: electrical stimulation (ES) and pulsed wound irrigation (PWI)<br>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 | Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)<br>* 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 high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bates-Jensen Wound Assessment Tool (BWAT) score | 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 | Baseline | 
| Bates-Jensen Wound Assessment Tool (BWAT) score | 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 | Week 1 | 
| Bates-Jensen Wound Assessment Tool (BWAT) score | 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 | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score | 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 | Baseline and Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Care, Physical Therapy, Pulsed wound irrigation, Electrical stimulation