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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05458947

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Pressure Injuries	Procedure: pulsed wound irrigation (PWI) Procedure: electrical stimulation (ES) Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

To examine the effects of PT wound care modalities (PWI + ES, PWI only, and ES only) on wound healing in patients with SCITo 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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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

Procedure: pulsed wound irrigation (PWI)

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

Experimental: 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

Procedure: electrical stimulation (ES)

high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes

Experimental: 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

Procedure: electrical stimulation (ES) and pulsed wound irrigation (PWI)

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

Outcome Measures

Primary Outcome Measures

Bates-Jensen Wound Assessment Tool (BWAT) score [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 [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
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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