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Recruiting NCT05458947

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

No phase Interventional Spinal Cord Injuries Pressure Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pulsed wound irrigation (PWI), electrical stimulation (ES), electrical stimulation (ES) and pulsed wound irrigation (PWI).
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Pressure Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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
  • 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
  • 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

Primary outcome measures

  • Bates-Jensen Wound Assessment Tool (BWAT) score [Time frame: Baseline]
  • Bates-Jensen Wound Assessment Tool (BWAT) score [Time frame: Week 1]
  • Bates-Jensen Wound Assessment Tool (BWAT) score [Time frame: Year 1]
Secondary outcome measures (1)
  • Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score [Time frame: Baseline and Year 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Carolinas Rehabilitation — Charlotte

Identifiers

NCT: NCT05458947 · IRB00085228

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗