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

Spinal Cord Injuries Clinical Trial

— (SCI)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458947
• Other study ID #: IRB00085228
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Erin Weeks, PT, DPT,WS
• Phone: 704-355-4461
• Email: erin.weeks[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Ulcer
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Carolinas Rehabilitation	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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