Trial results for a study investigating a bioelectric dressing for Hidradenitis Suppurativa (HS) were posted on ClinicalTrials.gov on 2026-03-06. The study enrolled a total of 12 participants.
Background
Hidradenitis Suppurativa is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and sinus tracts, primarily affecting areas with apocrine glands. Surgical de-roofing is a common procedure used to treat chronic or recurrent lesions by removing the roof of the sinus tracts, allowing the wound to heal by secondary intention. Optimizing post-surgical healing and reducing recurrence rates are critical goals in managing HS, as the condition often significantly impacts patients' quality of life. The study aimed to explore whether a bioelectric dressing could enhance the healing process after de-roofing.
Trial design
This completed study, designated as Phase NA, enrolled 12 participants with Hidradenitis Suppurativa. The primary purpose of this study was to test if the use of a bioelectric dressing could improve healing after a surgical procedure called de-roofing. Participants were assigned to either an intervention group receiving a bioelectric dressing or a control group receiving standard of care post-de-roofing treatment.
Key results
The trial reported several key measurements related to healing and recurrence:
- Healing Rate (cm^2/day):
- Intervention Group (Bioelectric Dressing): A mean healing rate of 0.45 (Standard Deviation 0.28) cm^2/day was observed.
- Control Group (Standard of Care): A mean healing rate of 0.39 (Standard Deviation 0.28) cm^2/day was observed.
- Average Time to Complete Healing (days):
- Intervention Group (Bioelectric Dressing): The mean time was 56 (Standard Deviation 0) days.
- Control Group (Standard of Care): The mean time was 56 (Standard Deviation 0) days.
- Number of Subjects With Complete Healing (participants):
- Intervention Group (Bioelectric Dressing): 2 participants achieved complete healing.
- Control Group (Standard of Care): 4 participants achieved complete healing.
- Number of Subjects With Nodule and/or Tunnel Recurrence (participants):
- Intervention Group (Bioelectric Dressing): 2 participants experienced recurrence.
- Control Group (Standard of Care): 6 participants experienced recurrence.
- Average Pain as Assessed by the Visual Analogue Scale (VAS) (units on a scale):
- Intervention Group (Bioelectric Dressing): A mean change of -1.5 (Standard Deviation 2.0) units was reported.
- Control Group (Standard of Care): A mean change of -1.9 (Standard Deviation 2.4) units was reported.
- Number of Subjects With Tenderness at Surgical Sites (participants):
- Intervention Group (Bioelectric Dressing): 12 participants reported tenderness.
- Control Group (Standard of Care): 11 participants reported tenderness.
What this means
The results from this small study suggest that a bioelectric dressing may offer some benefits in the post-surgical management of Hidradenitis Suppurativa after de-roofing. Notably, the intervention group showed a lower number of participants experiencing nodule and/or tunnel recurrence (2 vs 6 participants) compared to the standard of care group. While the mean healing rate was slightly higher in the intervention group (0.45 vs 0.39 cm^2/day), the average time to complete healing was identical (56 days) for both groups. However, fewer participants in the intervention group achieved complete healing (2 vs 4). Pain reduction, as measured by VAS, was similar between the groups, with both showing a decrease. These preliminary findings, from a limited number of participants, indicate a potential role for bioelectric dressings in reducing recurrence, but further research with larger cohorts is needed to confirm these observations and clarify their clinical significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05057429, titled "A Bioelectric Dressing for Post De-Roofing Treatment of HS", were posted on 2026-03-06 on clinicaltrials.gov.