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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.
Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease most frequently affecting the axilla, groin, and inframammary regions. Symptoms include nodules, abscesses, sinus tract formation, malodorous drainage, and scarring. These symptoms interfere with everyday activities, which can lead to social embarrassment and isolation. Patients with HS suffer psychological effects, such as increased levels of anxiety, depression, and loneliness, which impair quality of life.
Patients suffer with the burden of at home wound care for recurrent, draining nodules. Persistent lesions affect patients' lives by limiting their daily activities. Currently, patients are instructed to use gauze and tape to cover draining wounds, but this can be insufficient and difficult due to the nature and location of lesions associated with HS. Patients suffer with caring for their wounds, which can lead to frustration. Providing patients with a standard wound care regimen to take home can improve patients' quality of life and control of their disease. General recommendations for wound care in HS patients are limited. Improvements in the standard of care for wound management in HS are needed to aid patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylene blue, gentian violet, and ovine forestomach wound dressings | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Wound Size | Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products | Measure from Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Assessment Scores | 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 from baseline to week 1 |
| Change in Pain Assessment Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita O Pichardo, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences Dermatology | Winston-Salem | North Carolina | 27104 | United States |
This is a pilot study to determine use and outcomes; the plan is to be able to provide overall group data since it is such a small set of participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | methylene 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | methylene 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Wound Size | Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products | Posted | Mean | Full Range | percentage change in wound size | Measure from Baseline to week 8 |
|
Baseline, 1 week, 2 week, 4 week, 8 week
There were no adverse events report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | methylene 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Administrative Coordinator | Wake Forest | 336-716-2903 | irichard@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2021 | Aug 27, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2021 | Jun 27, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| D005840 | Gentian Violet |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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Case series
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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 from week1 to week 2 |
| Change in Pain Assessment Scores | 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 from week 2 to week 4 |
| Change in Pain Assessment Scores | 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 from week 4 to week 8 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Pain Assessment Scores | 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 | Mean | Full Range | score on a scale | Change from baseline to week 1 |
|
|
|
| Secondary | Change in Pain Assessment Scores | 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 | Mean | Full Range | score on a scale | Change from week1 to week 2 |
|
|
|
| Secondary | Change in Pain Assessment Scores | 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 | Mean | Full Range | score on a scale | Change from week 2 to week 4 |
|
|
|
| Secondary | Change in Pain Assessment Scores | 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 | Mean | Full Range | score on a scale | Change from week 4 to week 8 |
|
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| Post-Hoc | Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Wound Healing Time was not analyzed | Posted | Change from week 4 to week 8 |
|
|
| Post-Hoc | Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Wound Healing Time was not analyzed | Posted | Change from week 2 to week 4 |
|
|
| Post-Hoc | Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Wound Healing Time was not analyzed | Posted | Change from week 1 to week 2 |
|
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| Post-Hoc | Wound Healing Time | Assess the time for wound healing to occur using Endoform and Hydrofera Blue products. | Wound Healing Time was not analyzed | Posted | Change from baseline to week 1 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000814 | Aniline Compounds |
| D000588 | Amines |