Trial Outcomes & Findings for Hidradenitis Suppurativa Wound Care (NCT NCT04354012)
NCT ID: NCT04354012
Last Updated: 2025-10-22
Results Overview
Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Measure from Baseline to week 8
Results posted on
2025-10-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hidradenitis Suppurativa Wound Care
Baseline characteristics by cohort
| Measure |
Treatment
n=5 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measure from Baseline to week 8Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
|
|---|---|
|
Percent Change in Wound Size
|
57.2 percentage change in wound size
Interval 4.6 to 100.0
|
SECONDARY outcome
Timeframe: Change from baseline to week 1Assess 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.
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
|
|---|---|
|
Change in Pain Assessment Scores
|
5 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Change from week1 to week 2Assess 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.
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
|
|---|---|
|
Change in Pain Assessment Scores
|
3.8 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Change from week 2 to week 4Assess 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.
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
|
|---|---|
|
Change in Pain Assessment Scores
|
4.2 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Change from week 4 to week 8Assess 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.
Outcome measures
| Measure |
Treatment
n=4 Participants
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.
|
|---|---|
|
Change in Pain Assessment Scores
|
3.12 score on a scale
Interval 0.0 to 8.0
|
POST_HOC outcome
Timeframe: Change from week 4 to week 8Population: Wound Healing Time was not analyzed
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Change from week 2 to week 4Population: Wound Healing Time was not analyzed
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Change from week 1 to week 2Population: Wound Healing Time was not analyzed
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Change from baseline to week 1Population: Wound Healing Time was not analyzed
Assess the time for wound healing to occur using Endoform and Hydrofera Blue products.
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place