What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa, such as the combination of Endoform, Hydrofera Blue, and Hypafix tape, generally aim to manage wounds and prevent infection. Side effects of these treatments can include local skin irritation, allergic reactions, and contact dermatitis. Methlyene blue and gentian violet, which have antimicrobial properties, may cause skin staining and, in rare cases, hypersensitivity reactions. Overall, these treatments are well-tolerated, but patients should monitor for any signs of adverse reactions and consult their healthcare provider if they occur.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa, including biologics like adalimumab (Humira), which targets inflammatory pathways. While there is no specific mention of FDA approval for the combination of Endoform, Hydrofera Blue, and Hypafix tape, these products are used for their antimicrobial and wound healing properties. Endoform, derived from ovine forestomach, aids in wound healing, while Hydrofera Blue, containing methylene blue and gentian violet, provides antimicrobial effects. These components are commonly used in wound care management but may not be specifically approved for HS by the FDA.

What other types of research exist?

Promising novel alternatives for treating Hidradenitis Suppurativa wounds include: 1) Fibrin sealants and bovine collagen, which have shown positive effects on wound healing. 2) Omega-3 enriched diets and magnetic field therapy, which are being studied for their healing properties. 3) New biological tissue adhesives, macrophage stimulants, and thromboxane-synthetase inhibitors, which are under investigation for their potential to enhance wound healing. These alternatives may offer improved outcomes for HS patients.

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Combination Product

Combination Wound Care for Hidradenitis Suppurativa

Phase 2

Waitlist Available

Led By Rita O Pichardo, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules

Be older than 18 years old

Must not have

Individuals younger than 18 years of age

Individuals without a diagnosis of HS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from week 4 to week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a combination of sheep stomach material, special wound covering, and adhesive to help heal wounds in patients with Hidradenitis suppurativa. These patients have chronic, painful wounds that are hard to manage. The treatment helps by providing a structure for new skin, preventing infections, and keeping the wound covered.

Who is the study for?

This trial is for adults over 18 with hidradenitis suppurativa (HS) who have non-healing wounds or draining abscesses/nodules. It's not open to those under 18 or without an HS diagnosis.

What is being tested?

The study is testing the effectiveness of a wound care regimen using methylene blue, gentian violet, and ovine forestomach dressings on healing HS-related wounds.

What are the potential side effects?

Potential side effects may include skin irritation, allergic reactions to the dressing materials, and discoloration of the skin where treatments are applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have hidradenitis suppurativa with wounds or abscesses that won't heal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I have not been diagnosed with hidradenitis suppurativa (HS).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from week 4 to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from week 4 to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from week 4 to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of Wound Healing

Wound Healing Time

Secondary study objectives

Pain Assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The combination of Endoform, Hydrofera Blue, and Hypafix tape leverages the antimicrobial properties of methylene blue and gentian violet, along with the wound healing benefits of ovine forestomach. Methylene blue and gentian violet act as antiseptics, reducing bacterial load and preventing infection, which is crucial for managing the chronic and recurrent nature of HS lesions. The ovine forestomach component promotes tissue regeneration and wound healing. These mechanisms are vital for HS patients as they help control infection, reduce inflammation, and enhance healing of the painful and persistent wounds characteristic of the condition. Other common treatments, such as antibiotics, biologics, and surgical interventions, also aim to reduce inflammation, control infection, and promote healing, addressing the multifaceted pathology of HS.

Management of hidradenitis suppurativa.