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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to heal wounds caused by hidradenitis suppurativa (HS), a condition that results in painful, recurring skin bumps and tunnels. The study focuses on using special wound dressings made from methylene blue, gentian violet, and ovine forestomach (sheep stomach tissue) to evaluate the speed and effectiveness of wound healing. Individuals with HS who have non-healing wounds or draining abscesses may be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that a combination of methylene blue, gentian violet, and special wound dressings made from sheep stomach lining is generally safe for treating wounds. These dressings help manage hidradenitis suppurativa, a painful skin condition, by keeping wounds clean and reducing bacteria. Described as non-cytotoxic, the product does not harm living cells, suggesting it is well-tolerated by patients.

Studies indicate that these dressings can be worn for a week without causing irritation, demonstrating their safety. So far, no major side effects have been reported with these dressings, making them a promising option for people dealing with this challenging condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HS?

Researchers are excited about this treatment for Hidradenitis Suppurativa (HS) because it combines methylene blue, gentian violet, and ovine forestomach wound dressings, offering a potentially innovative approach. Unlike traditional options like antibiotics and surgery, this combination targets HS lesions with unique active ingredients that have antimicrobial properties. The use of ovine forestomach wound dressings is particularly interesting as it may enhance healing by providing a natural scaffold for tissue repair. This multifaceted approach could lead to more effective and faster relief for individuals suffering from this painful condition.

What evidence suggests that this combination wound care treatment might be effective for Hidradenitis Suppurativa?

Research has shown that a combination of methylene blue, gentian violet, and special dressings made from sheep stomach can effectively treat wounds in people with hidradenitis suppurativa (HS). In this trial, participants will receive these dressings, which possess antibacterial properties that help reduce infections in wounds. Studies have found that this type of wound care can be used for a week without slowing the healing process. Patients have reported an improved quality of life with these dressings, as they help HS wounds heal faster. Overall, these treatments are safe and non-toxic, making them a promising option for those with HS. ^{1 3 5 6 7}

Who Is on the Research Team?

Rita Pichardo, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04354012

NCT04354012 | Hidradenitis Suppurativa Wound Care

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 ...

2.

ctv.veeva.com

ctv.veeva.com/study/hidradenitis-suppurativa-wound-care

Hidradenitis Suppurativa Wound Care - ClinicalTrials.Veeva

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 ...

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/12/NCT04354012/Prot_SAP_001.pdf

Project Summary (limit to 5 pages)

This will be a single-center, case series evaluating the length of time wound healing occurs using methylene blue, gentian violet, and ovine forestomach wound ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10307738/

The Current Clinical Trial Landscape for Hidradenitis ...

The combination of methylene blue with gentian violet serves as an antibacterial foam dressing that can be worn for a week without inhibiting ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10366058/

Emerging Treatments and the Clinical Trial Landscape for ...

Wound dressings improve quality of life for hidradenitis suppurativa patients. J Am Acad Dermatol. 2022;86(2):450–453. doi: 10.1016/j.jaad ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04354012?tab=history&a=32

Record History | ver. 32: 2025-07-29 | NCT04354012

methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions. Combination Product: methylene blue, gentian violet, and ovine ...

7.

link.springer.com

link.springer.com/article/10.1007/s13555-023-00957-5

Procedural and Wound Care Therapies

Wound dressings improve quality of life for hidradenitis suppurativa patients. J Am Acad Dermatol. 2022;86(2):450–3. https://doi.org/10.1016 ...