Hidradenitis Suppurativa Wound Care

Phase 2

Active, not recruiting

• Conditions: Hidradenitis Suppurativa (HS)
• Interventions: Combination Product: methylene blue, gentian violet, and ovine forestomach wound dressings

• Registration Number: NCT04354012
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2021-02-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules
• Individuals over 18 years of age

Read More

Exclusion Criteria

• Individuals younger than 18 years of age
• Individuals without a diagnosis of HS

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	methylene blue, gentian violet, and ovine forestomach wound dressings	methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain Assessment	Change from week 4 to week 8	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.

Trial Locations

Locations (1)

Wake Forest Health Sciences Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States