Hidradenitis Suppurativa Wound Care
Primary Purpose
Hidradenitis Suppurativa (HS)
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
methylene blue, gentian violet, and ovine forestomach wound dressings
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa (HS)
Eligibility Criteria
Inclusion Criteria:
- Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules
- Individuals over 18 years of age
Exclusion Criteria:
- Individuals younger than 18 years of age
- Individuals without a diagnosis of HS
Sites / Locations
- Wake Forest Health Sciences Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions
Outcomes
Primary Outcome Measures
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Percent of Wound Healing
Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products
Secondary Outcome Measures
Pain Assessment
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Pain Assessment
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Pain Assessment
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Pain Assessment
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Full Information
NCT ID
NCT04354012
First Posted
April 16, 2020
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04354012
Brief Title
Hidradenitis Suppurativa Wound Care
Official Title
Prospective Case Series on a Combination Methylene Blue, Gentian Violet, and Ovine Forestomach-derived Extracellular Matrix Dressing for Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this case series is to monitor time and outcome of healing of wounds associated with HS using Endoform [ovine forestomach], Hydrofera Blue [methylene blue and gentian violet], and Hypafix tape. a combination methylene blue, gentian violet, and ovine forestomach wound care product.
Detailed Description
Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease most frequently affecting the axilla, groin, and inframammary regions. Symptoms include nodules, abscesses, sinus tract formation, malodorous drainage, and scarring. These symptoms interfere with everyday activities, which can lead to social embarrassment and isolation. Patients with HS suffer psychological effects, such as increased levels of anxiety, depression, and loneliness, which impair quality of life.
Patients suffer with the burden of at home wound care for recurrent, draining nodules. Persistent lesions affect patients' lives by limiting their daily activities. Currently, patients are instructed to use gauze and tape to cover draining wounds, but this can be insufficient and difficult due to the nature and location of lesions associated with HS. Patients suffer with caring for their wounds, which can lead to frustration. Providing patients with a standard wound care regimen to take home can improve patients' quality of life and control of their disease. General recommendations for wound care in HS patients are limited. Improvements in the standard of care for wound management in HS are needed to aid patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa (HS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions
Intervention Type
Combination Product
Intervention Name(s)
methylene blue, gentian violet, and ovine forestomach wound dressings
Intervention Description
Hydrofera Blue is an antibacterial foam dressing that contains methylene blue and gentian violet to manage wounds. This is a safe, non-cytotoxic product that can be worn for 7 days while not inhibiting growth factors. This products wicks bacteria into the foam and away from the wound surface using natural negative pressure through capillary flow.
Endoform (ovine forestomach) is a natural dermal template used in all phases of wound healing. This product helps to stabilize, build, and organize tissue in acute and chronic wounds.
Hypafix tape aids in stabilization of wound dressings. This productIt is easy to apply, skin friendly, and comfortable to use.
Primary Outcome Measure Information:
Title
Wound Healing Time
Description
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time Frame
Change from baseline to week 1
Title
Wound Healing Time
Description
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time Frame
Change from week 1 to week 2
Title
Wound Healing Time
Description
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time Frame
Change from week 2 to week 4
Title
Wound Healing Time
Description
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time Frame
Change from week 4 to week 8
Title
Percent of Wound Healing
Description
Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products
Time Frame
Measure from Baseline to week 8
Secondary Outcome Measure Information:
Title
Pain Assessment
Description
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Time Frame
Change from baseline to week 1
Title
Pain Assessment
Description
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Time Frame
Change from week1 to week 2
Title
Pain Assessment
Description
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Time Frame
Change from week 2 to week 4
Title
Pain Assessment
Description
Assess changes in patient reported pain via Numerical Rating Scale of Pain (NRS) a scale using a number from 0 to 10 where 0 is no pain or hurt and 10 is the most or worst pain.
Time Frame
Change from week 4 to week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules
Individuals over 18 years of age
Exclusion Criteria:
Individuals younger than 18 years of age
Individuals without a diagnosis of HS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita O Pichardo, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a pilot study to determine use and outcomes; the plan is to be able to provide overall group data since it is such a small set of participants.
Learn more about this trial
Hidradenitis Suppurativa Wound Care
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