Hidradenitis Suppurativa (HS)NCT07316192
Pelashield™ PainGuard™ vs Restrata® in HS Surgery
A study testing Pelashield Painguard in people with Hidradenitis Suppurativa (HS), run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Pelashield Painguard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surgical excision.
- Ability to provide informed consent in English.
- Willingness and ability to attend routine postoperative follow-up visits to monitor healing and readiness for second-stage closure.
Who cannot join
- Non-English-speaking patients (due to consent and follow-up communication limitations).
- Known allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver.
- Known sensitivity to lidocaine or history of cardiac conditions contraindicating lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome).
- Pregnancy or active breastfeeding.
- Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 <200, or chronic systemic steroids >10 mg prednisone-equivalent/day).
- Uncontrolled diabetes (most recent HbA1c >10% if available within 3 months).
- Active systemic infection or sepsis at time of surgery.
- Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospital
Newark, New Jersey, 07103
Mark Granick, MD, 973-972-5377, granickm@njms.rutgers.edu
Neil Reddy, BS, 732-604-5296, nr564@njms.rutgers.edu
About this study
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
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:
Read more
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Pelashield Painguard
- Keywords
- Prospective, Wide local Excision, Wound Healing
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelashield PainguardDevice
This is the only intervention being used in this study
| Study group | Role | What they receive |
|---|---|---|
| Pelashield™ PainGuard™ Group | Experimental | 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 Receives: Device: Pelashield Painguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Analgesic Usage
Total cumulative opioid consumption during two distinct postoperative periods:
Measured: Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2
ReCell Skin Graft Incorporation
Percentage of the Stage 2 wound bed demonstrating successful ReCell graft take, reflecting the quality of granulation tissue and bacterial burden of the wound bed at time of grafting.
Measured: Assessment performed at 14 days (±3 days) post-Stage 2 during routine clinic follow-up
Surgical Site Infection (SSI) During Wound Bed Preparation
Presence of a clinically diagnosed surgical site infection occurring between Stage 1 excision and Stage 2 closure as defined by CDC criteria.
Measured: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)
Time to Definitive Closure (Granulation Readiness)
Number of days from Stage 1 excision to Stage 2 definitive closure (debridement and ReCell application).
Measured: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)
Secondary outcomes (1)
Postoperative Non-Opioid Analgesic Use
Measured: Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Granick, MD, FACS, Rutgers, The State University of New Jersey
- Investigators
- Mark Granick, MD, Principal investigator, New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316192
- Sponsor's protocol ID
- Pro2025001853
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The findings from this study are intended to contribute to the scientific literature and will likely be disseminated through peer-reviewed publication or presentation at academic meetings. Participants will continue to receive all clinically relevant information about their own care and outcomes during routine follow-up visits, but they will not receive individual or aggregate research results unless they specifically request them after study completion.
Publications
Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2(Suppl 2):1-19. doi: 10.1111/j.1742-481X.2012.01097.x.
PubMed 23145905Wounds UK. International consensus. Appropriate use of silver dressings in wounds. Wounds UK. 2012;8(1):1-28.
MacEwan MR, MacEwan S, Kovacs TR, Batts J. What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus. 2017 Oct 2;9(10):e1736. doi: 10.7759/cureus.1736.
PubMed 29209583Matusiak L, Bieniek A, Szepietowski JC. Psychophysical aspects of hidradenitis suppurativa. Acta Derm Venereol. 2010 May;90(3):264-8. doi: 10.2340/00015555-0866.
PubMed 20526543Ring HC, Sorensen H, Miller IM, List EK, Saunte DM, Jemec GB. Pain in Hidradenitis Suppurativa: A Pilot Study. Acta Derm Venereol. 2016 May;96(4):554-6. doi: 10.2340/00015555-2308. No abstract available.
PubMed 26631388Scuderi N, Alfano C, Paolini G, et al. Surgical treatment of hidradenitis suppurativa: evaluation of two methods and postoperative outcome analysis. Int Wound J. 2013;10(4):435-441.
Kohorst JJ, Baum CL, Otley CC, Roenigk RK, Schenck LA, Pemberton JH, Dozois EJ, Tran NV, Senchenkov A, Davis MD. Surgical Management of Hidradenitis Suppurativa: Outcomes of 590 Consecutive Patients. Dermatol Surg. 2016 Sep;42(9):1030-40. doi: 10.1097/DSS.0000000000000806.
PubMed 27340739Alavi A, Lynde C, Alhusayen R, Bourcier M, Delorme I, George R, Gooderham M, Gulliver W, Kalia S, Marcoux D, Poulin Y. Approach to the Management of Patients With Hidradenitis Suppurativa: A Consensus Document. J Cutan Med Surg. 2017 Nov/Dec;21(6):513-524. doi: 10.1177/1203475417716117. Epub 2017 Jun 22.
PubMed 28639459Mehdizadeh A, Hazen PG, Bechara FG, et al. A comprehensive review of surgical treatment in hidradenitis suppurativa. Dermatol Surg. 2015;41(Suppl 1):S149-S164.
Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.
PubMed 22236226
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07316192
- Acronym / sponsor ID
- Pro2025001853
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Prospective, Wide local Excision, Wound Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelashield™ PainGuard™ Group | Experimental | Device: Pelashield PainguardProcedures: Perform wide excision of HS-affected tissue Apply Pelashield™ PainGuard™ to cover the surgical wound Place wound dressing and provide standard postoperative care instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surgical excision.
- Ability to provide informed consent in English.
- Willingness and ability to attend routine postoperative follow-up visits to monitor healing and readiness for second-stage closure.
Key exclusion criteria (8 listed)
- Non-English-speaking patients (due to consent and follow-up communication limitations).
- Known allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver.
- Known sensitivity to lidocaine or history of cardiac conditions contraindicating lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome).
- Pregnancy or active breastfeeding.
- Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 <200, or chronic systemic steroids >10 mg prednisone-equivalent/day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelashield PainguardThis is the only intervention being used in this study | Device | Pelashield™ PainGuard™ Group |
Primary outcome
Postoperative Opioid Analgesic Usage
Time frame: Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2
Total cumulative opioid consumption during two distinct postoperative periods:
ReCell Skin Graft Incorporation
Time frame: Assessment performed at 14 days (±3 days) post-Stage 2 during routine clinic follow-up
Percentage of the Stage 2 wound bed demonstrating successful ReCell graft take, reflecting the quality of granulation tissue and bacterial burden of the wound bed at time of grafting.
Surgical Site Infection (SSI) During Wound Bed Preparation
Time frame: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)
Presence of a clinically diagnosed surgical site infection occurring between Stage 1 excision and Stage 2 closure as defined by CDC criteria.
Time to Definitive Closure (Granulation Readiness)
Time frame: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1)
Number of days from Stage 1 excision to Stage 2 definitive closure (debridement and ReCell application).
1 secondary outcome
Postoperative Non-Opioid Analgesic Use
Time frame: Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 23145905Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2(Suppl 2):1-19. doi: 10.1111/j.1742-481X.2012.01097.x.
- BackgroundWounds UK. International consensus. Appropriate use of silver dressings in wounds. Wounds UK. 2012;8(1):1-28.
- Background: PubMed 29209583MacEwan MR, MacEwan S, Kovacs TR, Batts J. What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus. 2017 Oct 2;9(10):e1736. doi: 10.7759/cureus.1736.
- Background: PubMed 20526543Matusiak L, Bieniek A, Szepietowski JC. Psychophysical aspects of hidradenitis suppurativa. Acta Derm Venereol. 2010 May;90(3):264-8. doi: 10.2340/00015555-0866.
- Background: PubMed 26631388Ring HC, Sorensen H, Miller IM, List EK, Saunte DM, Jemec GB. Pain in Hidradenitis Suppurativa: A Pilot Study. Acta Derm Venereol. 2016 May;96(4):554-6. doi: 10.2340/00015555-2308. No abstract available.
- BackgroundScuderi N, Alfano C, Paolini G, et al. Surgical treatment of hidradenitis suppurativa: evaluation of two methods and postoperative outcome analysis. Int Wound J. 2013;10(4):435-441.
- Background: PubMed 27340739Kohorst JJ, Baum CL, Otley CC, Roenigk RK, Schenck LA, Pemberton JH, Dozois EJ, Tran NV, Senchenkov A, Davis MD. Surgical Management of Hidradenitis Suppurativa: Outcomes of 590 Consecutive Patients. Dermatol Surg. 2016 Sep;42(9):1030-40. doi: 10.1097/DSS.0000000000000806.
- Background: PubMed 28639459Alavi A, Lynde C, Alhusayen R, Bourcier M, Delorme I, George R, Gooderham M, Gulliver W, Kalia S, Marcoux D, Poulin Y. Approach to the Management of Patients With Hidradenitis Suppurativa: A Consensus Document. J Cutan Med Surg. 2017 Nov/Dec;21(6):513-524. doi: 10.1177/1203475417716117. Epub 2017 Jun 22.
- BackgroundMehdizadeh A, Hazen PG, Bechara FG, et al. A comprehensive review of surgical treatment in hidradenitis suppurativa. Dermatol Surg. 2015;41(Suppl 1):S149-S164.
- Background: PubMed 22236226Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.
- Individual participant dataSharing planned: No. The findings from this study are intended to contribute to the scientific literature and will likely be disseminated through peer-reviewed publication or presentation at academic meetings. Participants will continue to receive all clinically relevant information about their own care and outcomes during routine follow-up visits, but they will not receive individual or aggregate research results unless they specifically request them after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Granick, MD principal investigator
New Jersey Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelashield Painguard in people with Hidradenitis Suppurativa (HS), run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neil Reddy, BS (732-604-5296, nr564@njms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Opioid Analgesic Usage (time frame: Period 1: After Stage 1 excision through day before Stage 2 closure (up to 8 weeks starting one day after surgery 1) Period 2: Stage 2 closure through 30 days post-Stage 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07316192, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.