Hidradenitis Suppurativa (HS)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTmethylene 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Case series
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Wound Size | Measure from Baseline to week 8 | Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Assessment Scores | Change from baseline to week 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 37.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Percent Change in Wound Size
Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products
Time frame: Measure from Baseline to week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Percent Change in Wound Size | 57.2 percentage change in wound size |
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.
Time frame: Change from week 4 to week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Change in Pain Assessment Scores | 3.12 score on a scale |
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.
Time frame: Change from week 2 to week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Change in Pain Assessment Scores | 4.2 score on a scale |
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.
Time frame: Change from baseline to week 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Change in Pain Assessment Scores | 5 score on a scale |
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.
Time frame: Change from week1 to week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Change in Pain Assessment Scores | 3.8 score on a scale |
Post Hoc
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time frame: Change from baseline to week 1
Population: Wound Healing Time was not analyzed
Post Hoc
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time frame: Change from week 4 to week 8
Population: Wound Healing Time was not analyzed
Post Hoc
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time frame: Change from week 2 to week 4
Population: Wound Healing Time was not analyzed
Post Hoc
Wound Healing Time
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Time frame: Change from week 1 to week 2
Population: Wound Healing Time was not analyzed