Clinical trial
Prospective Case Series on a Combination Methylene Blue, Gentian Violet, and Ovine Forestomach-derived Extracellular Matrix Dressing for Hidradenitis Suppurativa
Name
IRB00063673
Description
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.
Trial arms
Trial start
2021-02-04
Estimated PCD
2024-10-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Treatment
Size
5
Primary endpoint
Wound Healing Time
Change from baseline to week 1
Wound Healing Time
Change from week 1 to week 2
Wound Healing Time
Change from week 2 to week 4
Wound Healing Time
Change from week 4 to week 8
Percent of Wound Healing
Measure from Baseline to week 8
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case series', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2024-05-23
1 organization
1 product
1 indication
Organization
Wake Forest University Health SciencesIndication
Hidradenitis Suppurativa