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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Spinal Cord Injuries; Pressure Injuries

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05458947

IRB00085228

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

pulsed wound irrigation (PWI)

Experimental group

Description:

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

Treatment:

Procedure: pulsed wound irrigation (PWI)

electrical stimulation (ES)

Experimental group

Description:

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

Treatment:

Procedure: electrical stimulation (ES)

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

Experimental group

Description:

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

Treatment:

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