Combination Wound Care for Hidradenitis Suppurativa

Overseen By Research Administrative Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, No HS diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the combination wound care treatment for hidradenitis suppurativa differ from other treatments?

This treatment is unique because it combines methylene blue and gentian violet, which have antimicrobial properties, with ovine forestomach wound dressings that promote healing, offering a novel approach compared to standard treatments like antibiotics or biologics. The use of methylene blue in photodynamic therapy has shown promise in treating hidradenitis suppurativa by targeting bacterial biofilms, which are often resistant to antibiotics. ^{1 2 3 4 5}

Research Team

Rita Pichardo, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

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

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

4 weeks

Follow-up

Participants are monitored for wound healing and pain assessment

8 weeks

Treatment Details

Interventions

• methylene blue, gentian violet, and ovine forestomach wound dressings

Trial Overview 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.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

Hidradenitis suppurativa (HS) is a challenging condition to treat, but recent guidelines recommend a combination of medical and surgical therapies, reflecting a growing understanding of the disease's complexity.

A systematic review of 365 papers identified 79 relevant studies, highlighting promising treatments such as infliximab, adalimumab, and ustekinumab, indicating a significant need for continued development of effective therapies for HS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New treatment strategies for hidradenitis suppurativa. Andersen, R., Jemec, GB.[2018]

A systematic review of 5310 articles led to the analysis of 171 studies, resulting in evidence-based recommendations for managing hidradenitis suppurativa (HS), emphasizing the use of topical clindamycin for mild cases and biologic therapy like adalimumab for more severe cases after conventional treatments fail.

The review established that local surgical excision is recommended for mild-to-moderate HS, while more extensive disease may require wide excision, highlighting the need for tailored treatment approaches based on disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. Zouboulis, CC., Bechara, FG., Dickinson-Blok, JL., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with intralesional methylene blue and a 635 nm light-emitting diode lamp in hidradenitis suppurativa: a retrospective follow-up study in 7 patients and a review of the literature. [2017]

2. Spain pubmed.ncbi.nlm.nih.gov

New treatment strategies for hidradenitis suppurativa. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Treating hidradenitis suppurativa with photodynamic therapy. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Patient perspectives of wound care management in hidradenitis suppurativa. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. [2020]