Clinical trial NCT04354012: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa (HS)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound Healing Time
timeFrame: Change from baseline to week 1
measure: Wound Healing Time
timeFrame: Change from week 1 to week 2
measure: Wound Healing Time
timeFrame: Change from week 2 to week 4
measure: Wound Healing Time
timeFrame: Change from week 4 to week 8
measure: Percent of Wound Healing
timeFrame: Measure from Baseline to week 8
Secondary outcomes:
measure: Pain Assessment
timeFrame: Change from baseline to week 1
measure: Pain Assessment
timeFrame: Change from week1 to week 2
measure: Pain Assessment
timeFrame: Change from week 2 to week 4
measure: Pain Assessment
timeFrame: Change from week 4 to week 8
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rita O Pichardo, MD
role: PRINCIPAL_INVESTIGATOR
References: