Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:01 AM
Study NCT ID:
NCT07316192
Status:
RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelashield™ PainGuard™ vs Restrata® in HS Surgery
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Outcomes With Pelashield™ PainGuard™ Compared to Restrata® in Standard Two-Stage Excision and Closure for Hidradenitis Suppurativa: A Prospective Cohort With Retrospective Comparator
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hidradenitis Suppurativa (HS) is a long-lasting skin condition that causes painful lumps and infections. In severe cases, patients need surgery to remove the affected skin. After surgery, a wound dressing called a wound matrix is placed over the area to help the skin heal.
This study will compare two different wound matrices:
Restrata®, which is the current standard treatment. Pelashield™ PainGuard™, a newer dressing that contains silver to reduce bacteria and lidocaine to help with pain.
The goal of this research is to find out if Pelashield™ PainGuard™ helps patients heal better after surgery than Restrata®. We will look at:
How quickly healthy granulation tissue (new healing tissue) forms How soon the wound is ready for the second surgery to apply a skin graft How often infections happen after surgery How much narcotic (opioid) pain medication patients need after surgery Patients who receive Pelashield™ PainGuard™ will be enrolled in the study going forward (prospective group). Patients who previously had surgery with Restrata® will be included through a review of their medical records (retrospective group). No additional procedures will be done outside of standard surgical care.
This study will compare two different wound matrices:
Restrata®, which is the current standard treatment. Pelashield™ PainGuard™, a newer dressing that contains silver to reduce bacteria and lidocaine to help with pain.
The goal of this research is to find out if Pelashield™ PainGuard™ helps patients heal better after surgery than Restrata®. We will look at:
How quickly healthy granulation tissue (new healing tissue) forms How soon the wound is ready for the second surgery to apply a skin graft How often infections happen after surgery How much narcotic (opioid) pain medication patients need after surgery Patients who receive Pelashield™ PainGuard™ will be enrolled in the study going forward (prospective group). Patients who previously had surgery with Restrata® will be included through a review of their medical records (retrospective group). No additional procedures will be done outside of standard surgical care.
Detailed Description:
Standard of Care vs. Research:
Wide surgical excision for Hidradenitis Suppurativa at University Hospital follows a standard two-stage approach: excision with wound matrix placement (Stage 1) followed by debridement and definitive closure with ReCell application (Stage 2). Currently, Restrata® wound matrix is our standard of care.
Research Component:
This study compares outcomes between our current standard (Restrata®) and an alternative FDA-cleared wound matrix (Pelashield™ PainGuard™) to determine whether Pelashield is a superior product. The research involves systematic data collection and comparison; all surgical procedures remain University Hospital standard of care.
Wide surgical excision for Hidradenitis Suppurativa following University Hospital's standard of care is often complicated by postoperative pain and poor skin graft adherence due to underlying bacterial overgrowth. Restrata® and Pelashield™ PainGuard™ are both synthetic wound matrices with FDA 510k clearance for use in surgical wounds. Pelashield™ PainGuard™ contains antimicrobial silver and local anesthetic, which may reduce postoperative pain and infection compared to Restrata®, and may provide a cleaner, more robust skin layer for enhanced wound healing and improved adherence of skin grafts. Additionally, the lower cost of Pelashield compared to Restrata aligns with University Hospital's commitment to responsible resource utilization and financial stewardship.
Specific Aim: To evaluate whether Pelashield™ PainGuard™, when used in place of Restrata® for wide excision of hidradenitis suppurativa, results in reduced narcotic pain medication use, reduced time to second procedure, and improved skin graft incorporation at wound site.
Wide surgical excision for Hidradenitis Suppurativa at University Hospital follows a standard two-stage approach: excision with wound matrix placement (Stage 1) followed by debridement and definitive closure with ReCell application (Stage 2). Currently, Restrata® wound matrix is our standard of care.
Research Component:
This study compares outcomes between our current standard (Restrata®) and an alternative FDA-cleared wound matrix (Pelashield™ PainGuard™) to determine whether Pelashield is a superior product. The research involves systematic data collection and comparison; all surgical procedures remain University Hospital standard of care.
Wide surgical excision for Hidradenitis Suppurativa following University Hospital's standard of care is often complicated by postoperative pain and poor skin graft adherence due to underlying bacterial overgrowth. Restrata® and Pelashield™ PainGuard™ are both synthetic wound matrices with FDA 510k clearance for use in surgical wounds. Pelashield™ PainGuard™ contains antimicrobial silver and local anesthetic, which may reduce postoperative pain and infection compared to Restrata®, and may provide a cleaner, more robust skin layer for enhanced wound healing and improved adherence of skin grafts. Additionally, the lower cost of Pelashield compared to Restrata aligns with University Hospital's commitment to responsible resource utilization and financial stewardship.
Specific Aim: To evaluate whether Pelashield™ PainGuard™, when used in place of Restrata® for wide excision of hidradenitis suppurativa, results in reduced narcotic pain medication use, reduced time to second procedure, and improved skin graft incorporation at wound site.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: