Pelashield™ PainGuard™ vs Restrata® in HS Surgery

NCT07316192 | Recruiting FDA Device

• 1 other identifier: Pro2025001853
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Prospective; Wide local Excision; Wound Healing

Outcome Measures

Primary Outcomes (4)

• Postoperative Opioid Analgesic Usage

  Total cumulative opioid consumption during two distinct postoperative periods:

  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.

  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.

  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).

  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

  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

Study Arms (1)

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

Device: Pelashield Painguard

Interventions

Pelashield Painguard DEVICE

This is the only intervention being used in this study

Pelashield™ PainGuard™ Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 23145905 BACKGROUND

• Wounds UK. International consensus. Appropriate use of silver dressings in wounds. Wounds UK. 2012;8(1):1-28.

  BACKGROUND

• 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.

  PMID: 29209583 BACKGROUND

• Matusiak L, Bieniek A, Szepietowski JC. Psychophysical aspects of hidradenitis suppurativa. Acta Derm Venereol. 2010 May;90(3):264-8. doi: 10.2340/00015555-0866.

  PMID: 20526543 BACKGROUND

• Ring 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.

  PMID: 26631388 BACKGROUND

• Scuderi 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

• 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.

  PMID: 27340739 BACKGROUND

• Alavi 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.

  PMID: 28639459 BACKGROUND

• Mehdizadeh 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

• Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.

  PMID: 22236226 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Mark Granick, MD

  New Jersey Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Reddy, BS

CONTACT

732-604-5296; nr564@njms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)