Pelashield PainGuard for Hidradenitis Suppurativa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new wound dressing, Pelashield™ PainGuard™, can improve healing after surgery for people with Hidradenitis Suppurativa (HS) compared to the current standard dressing. HS is a painful skin condition that sometimes requires surgery. The new dressing contains silver to combat bacteria and lidocaine to reduce pain. The trial seeks adults with HS who need surgery and can attend follow-up visits. As an unphased trial, this study allows patients to contribute to innovative research that could enhance post-surgical healing for HS.
What prior data suggests that Pelashield™ PainGuard™ is safe for wound healing after surgery?
Research shows that Pelashield™ PainGuard™ prioritizes safety. It contains silver to reduce bacteria and lidocaine to manage pain. Pelashield™ has been used to treat burn wounds, demonstrating its safety and effectiveness for complex wound care. Although specific data from past studies on its use in hidradenitis suppurativa (HS) surgery is lacking, its ingredients have been well-researched for safety.
This trial is not in a traditional clinical phase, indicating that Pelashield™ PainGuard™ is already deemed safe enough to test for effectiveness in this context. Current knowledge suggests no major safety concerns. However, it is important to consult a healthcare provider to understand how it might affect personal health.12345Why are researchers excited about this trial?
Unlike the standard treatments for Hidradenitis Suppurativa, which often include antibiotics, anti-inflammatory medications, and sometimes biologics, Pelashield™ PainGuard™ is unique because it integrates directly with surgical procedures. This treatment involves applying Pelashield™ PainGuard™ to the surgical wound after wide excision of affected tissue, potentially offering enhanced postoperative protection and pain management. Researchers are excited about this approach because it may provide a more efficient healing process and better pain control compared to traditional methods.
What evidence suggests that Pelashield™ PainGuard™ is effective for healing after surgery for Hidradenitis Suppurativa?
Research has shown that Pelashield™ PainGuard™ might aid healing after surgery for hidradenitis suppurativa (HS), a painful skin condition. The dressing contains silver to fight bacteria and lidocaine to reduce pain. This combination aims to accelerate the growth of new, healthy tissue. Early results suggest that PainGuard™ could reduce the need for strong pain medications after surgery. This trial tests whether Pelashield™ PainGuard™ can offer better outcomes for HS patients compared to the current standard treatment.678910
Who Is on the Research Team?
Mark Granick, MD
Principal Investigator
New Jersey Medical School
Are You a Good Fit for This Trial?
This trial is for individuals with Hidradenitis Suppurativa (HS) who require surgery. It's designed to compare two wound dressings post-surgery: Restrata®, the standard treatment, and Pelashield™ PainGuard™, which has silver and lidocaine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 Surgery and Wound Matrix Application
Perform wide excision of HS-affected tissue and apply wound matrix (Pelashield™ PainGuard™ or Restrata®) to cover the surgical wound
Postoperative Period 1
Monitor for surgical site infection and opioid analgesic usage from Stage 1 excision through day before Stage 2 closure
Stage 2 Surgery and ReCell Application
Debridement and definitive closure with ReCell application
Postoperative Period 2
Monitor opioid analgesic usage and ReCell skin graft incorporation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pelashield™ PainGuard™
Trial Overview
The study aims to determine if Pelashield™ PainGuard™ leads to better healing outcomes than Restrata® by assessing new tissue formation speed, readiness for skin grafting surgery, infection rates, and opioid pain medication needs after HS surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Procedures: Perform wide excision of HS-affected tissue Apply Pelashield™ PainGuard™ to cover the surgical wound Place wound dressing and provide standard postoperative care instructions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Citations
Trends in Hidradenitis Suppurativa Disease Severity and ...
Results: The HS Clinical Response (HiSCR) score (18/41, 44%) was the most commonly used instrument for disease severity, followed by the ...
Pelashield™ PainGuard™ vs Restrata® in HS Surgery
Specific Aim: To evaluate whether Pelashield™ PainGuard™, when used in place of Restrata® for wide excision of hidradenitis suppurativa, results ...
A Living Systematic Review and Network Meta-Analysis
Main outcomes and measures: Primary efficacy, safety, and tolerability outcomes were Hidradenitis Suppurativa Clinical Response (HiSCR)-50 ...
4.
dermatologyadvisor.com
dermatologyadvisor.com/news/outcomes-vary-surgical-intervention-used-hidradenitis-suppurativa/Outcomes Vary by Surgical Intervention Used for ...
Investigators assessed the therapeutic efficacy of various surgical interventions in patients with HS on patient-centered outcomes, ...
5.
spherixglobalinsights.com
spherixglobalinsights.com/wp-content/uploads/2024/11/Spherix-HS-White-Paper-_FINAL-PDF.pdfThe Key to Better Outcomes in Hidradenitis Suppurativa
Topical resorcinol, a keratolytic agent, has shown promise in reducing pain and the duration of flares in some patients. As the disease progresses or in cases ...
Pelashield™ PainGuard™ vs Restrata® in HS Surgery
Pelashield™ PainGuard™, a newer dressing that contains silver to reduce bacteria and lidocaine to help with pain. The goal of this research is ...
HidraWear Study for Hidradenitis Suppurativa Wounds
This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear AX in the home setting. Quality of life, ease of use and comfort of ...
Pelashield™ - Burn Wounds
Pelashield™ is a fully synthetic, hydrophilic, antimicrobial matrix specifically designed for complex challenges in burn wounds.1 Learn how Pelashield™ can ...
SAR445399 in Hidradenitis Suppurativa - Clinical Trials Registry
The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe ...
A Review of Hidradenitis Suppurativa in Special Populations
Biologic safety data for treating of HS during pregnancy are limited, but many biologics have been tested in pregnant patients for other inflammatory conditions ...
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