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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
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 SCI
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • 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
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
  • 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
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

Recruiting Locations

Carolinas Rehabilitation
Charlotte, North Carolina 28203

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

Erin Weeks, PT, DPT,WS
704-355-4461
Erin.Weeks@advocatehealth.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.