Back to resultsPhysical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI) ((SCI))
Primary Purpose
Spinal Cord Injuries, Pressure Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pulsed wound irrigation (PWI)
electrical stimulation (ES)
electrical stimulation (ES) and pulsed wound irrigation (PWI)
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Wound Care, Physical Therapy, Pulsed wound irrigation, Electrical stimulation
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
Sites / Locations
- Carolinas RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
pulsed wound irrigation (PWI)
electrical stimulation (ES)
electrical stimulation (ES) and pulsed wound irrigation (PWI)
Arm 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
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
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
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05458947
First Posted
July 6, 2022
Last Updated
May 24, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05458947
Brief Title
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Acronym
(SCI)
Official Title
A Prospective Analysis of Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Pressure Injuries
Keywords
Wound Care, Physical Therapy, Pulsed wound irrigation, Electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pulsed wound irrigation (PWI)
Arm Type
Experimental
Arm 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
Arm Title
electrical stimulation (ES)
Arm Type
Experimental
Arm 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
Arm Title
electrical stimulation (ES) and pulsed wound irrigation (PWI)
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
pulsed wound irrigation (PWI)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
electrical stimulation (ES)
Intervention Description
high volt pulsed current (HVPC) is most effective in wound healing while decreasing risk of adverse skin reactions or mild burns under the electrodes
Intervention Type
Procedure
Intervention Name(s)
electrical stimulation (ES) and pulsed wound irrigation (PWI)
Intervention Description
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 Measure Information:
Title
Bates-Jensen Wound Assessment Tool (BWAT) score
Description
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
Title
Bates-Jensen Wound Assessment Tool (BWAT) score
Description
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
Title
Bates-Jensen Wound Assessment Tool (BWAT) score
Description
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 Outcome Measure Information:
Title
Change in The Spinal Cord Injury Quality of Life measurement system (SCI-QOL) Short Form Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Weeks, PT, DPT,WS
Phone
704-355-4461
Email
erin.weeks@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Weeks, PT,DPT, CWS
Organizational Affiliation
Carolinas Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
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