Hidradenitis Suppurativa Wound Care

Hidradenitis Suppurativa (HS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04354012
• Other study ID #: IRB00063673
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Intervention

Combination Product:
• methylene blue, gentian violet, and ovine forestomach wound dressings
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.

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing Time	Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.	Change from baseline to week 1
Primary	Wound Healing Time	Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.	Change from week 1 to week 2
Primary	Wound Healing Time	Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.	Change from week 2 to week 4
Primary	Wound Healing Time	Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.	Change from week 4 to week 8
Primary	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	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
Secondary	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
Secondary	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
Secondary	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