Hidradenitis Suppurativa Wound Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Case Series on a Combination Methylene Blue, Gentian Violet, and Ovine Forestomach-derived Extracellular Matrix Dressing for Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa (HS)

Intervention / Treatment
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* Combination Product: methylene blue, gentian violet, and ovine forestomach wound dressings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Case series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions | Combination Product: methylene blue, gentian violet, and ovine forestomach wound dressings<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Change from baseline to week 1 | 
| Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Change from week 1 to week 2 | 
| Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Change from week 2 to week 4 | 
| Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Change from week 4 to week 8 | 
| Percent of Wound Healing | Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products | Measure from Baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to week 1 | 
| 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. | Change from week1 to week 2 | 
| 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. | Change from week 2 to week 4 | 
| 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. | Change from week 4 to week 8 |