Trial · Interventional

CompletedPhase 2Results postedRegistry data

Hidradenitis Suppurativa Wound Care

NCTNCT04354012Other idIRB00063673

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 5 participants (actual)
Sponsor: Wake Forest University Health Sciences · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 4 Feb 2021
Primary completion: 28 Aug 2024
Completion: 28 Aug 2024
First posted: 21 Apr 2020
Last update posted: 22 Oct 2025
Conditions: Hidradenitis Suppurativa (HS)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022202320242025

Ph 2
Hidradenitis Suppurativa Wound Care
NCT04354012
4 Feb 2021 to 28 Aug 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

methylene blue, gentian violet, and ovine forestomach wound dressingsCombination product

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change in Wound Size
Time frame · Measure from Baseline to week 8
Registry description
Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products

Secondary outcomes(4)

Change in Pain Assessment Scores
Time frame · Change from baseline to week 1
Registry description
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 in Pain Assessment Scores
Time frame · Change from week1 to week 2
Registry description
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 in Pain Assessment Scores
Time frame · Change from week 2 to week 4
Registry description
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 in Pain Assessment Scores
Time frame · Change from week 4 to week 8
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Measure from Baseline to week 8

Percent Change in Wound Size

Group	Value (percentage change in wound size)
Treatment	57.2

Secondary and other outcome results(7)

Secondary outcomeMean· Change from baseline to week 1

Change in Pain Assessment Scores

Group	Value (score on a scale)
Treatment	5

Secondary outcomeMean· Change from week1 to week 2

Change in Pain Assessment Scores

Group	Value (score on a scale)
Treatment	3.8

Secondary outcomeMean· Change from week 2 to week 4

Change in Pain Assessment Scores

Group	Value (score on a scale)
Treatment	4.2

Secondary outcomeMean· Change from week 4 to week 8

Change in Pain Assessment Scores

Group	Value (score on a scale)
Treatment	3.12

Post hoc outcome· Change from week 4 to week 8

Wound Healing Time

Group	Value
Treatment	not posted

Post hoc outcome· Change from week 2 to week 4

Wound Healing Time

Group	Value
Treatment	not posted

Post hoc outcome· Change from week 1 to week 2

Wound Healing Time

Group	Value
Treatment	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Treatmentmethylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions 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.	0 / 5	0 / 5	0 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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