About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 3 treatment groups

Group A: pulsed wound irrigation (PWI)Experimental treatment 1 intervention

Group B: electrical stimulation (ES)Experimental treatment 1 intervention

Group C: electrical stimulation (ES) and pulsed wound irrigation (PWI)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Baseline

2

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

Time frame

Week 1

3

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

Time frame

Year 1

Secondary outcomes

1

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

Time frame

Baseline and Year 1

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts