Infections

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasms

Digestive System Diseases

Crush Injuries

Communicable Diseases

Fistula

Hidradenitis Suppurativa

Hidradenitis

Pilonidal Sinus

Soft Tissue Infections

Rectal Fistula

Pressure Ulcer

Ulcer

Pathological Conditions, Anatomical

Sweat Gland Diseases

Skin Diseases

Skin Diseases, Bacterial

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Skin Diseases, Infectious

Suppuration

Intestinal Fistula

Digestive System Fistula

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Skin Ulcer

Cysts

Ovine forestomach matrix sheet graft and morselized extracellular matrix

Myriad Matrix™ and Myriad Morcells™

Barnaby May, PhD

Brandon Bosque, DMP,CWSP

Yosef Nasseri, MD, FACS, FACRS

Moshe Barnajian, MD, FACRS

Patrick Martyka, DPM

Alison Smith, MD, PhD

Frank Lau, MD

Research Coordinator

Joshua Wolf, MD

Tracee Short, MD

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures.

The study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention.

Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:

* Abdominal dehiscence
* Necrotizing soft tissue infection (NSTI)
* Lower extremity complex non-healing wounds (limb salvage)
* Pilonidal sinus disease
* Anal fistula
* Hidradenitis suppurativa reconstruction
* Pressure injury reconstruction

Other procedure types may be included at the discretion of the Investigator/Research Team.

Participants that are being enrolled in the study would otherwise be undergoing their surgical procedure with either of the Myriad™ devices as part of Standard of Care (SoC).

The pre-operative care and preparation of the surgical site (prior to the application of Myriad™ devices) shall be undertaken at the discretion of the attending physician and per their institutional protocols and procedures. Surgical technique for the participants reconstruction is at the discretion of the attending physician. Use of Myriad Matrix™ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrix™ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcells™ may be used for dermal regeneration and in combination with the Myriad Matrix™ devices. The participants post-operative care is at the discretion of the attending physician.

Early and late-stage healing outcomes will be assessed as part of the study and as part of standard of care.

Through the course of treatment and following up care de-identified patient data (quantitative qualitative assessment measures and digital images) will be captured and from the basis of the registry dataset.

Myriad™ Augmented Soft Tissue Reconstruction Registry

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

Nature, frequency, and severity of adverse events

When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded

Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures

Where applicable, when Myriad™ is used for dermal regeneration, the time until full graft integration will be recorded

Where applicable, when Myriad™ is used for dermal regeneration and a split thickness skin graft is used the percentage of graft take at 1 week will be recorded

Aroa Biosurgery Limited

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Hypertrophy

Cerebrospinal Fluid Leak

Skull Base Neoplasms

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Neurologic Manifestations

Craniocerebral Trauma

Trauma, Nervous System

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery

Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent

Participant will have silastic splint applied to nasoseptal flap harvest site

Non-Absorbable Packing (Silastic Splint)

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site

PuraGel (RADA16) Hydrogel

Satyan Sreenath, MD

The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.

Briefly, multiple agents exist and have been long-studied in endoscopic sinus and septal surgery, which include non-absorbable agents and biodegradable, absorbable synthetic agents including extracellular matrix (ECM) based compounds and synthetic biopolymers. The goal of these agents has often been to reduce sinonasal crusting, postoperative bleeding, and synechia formation. With advancements in postoperative adjuncts, many options now exist for postoperative sinonasal packing including medicated products such as steroid-impregnated stents and chitosan-based absorbable packs.

Lastly, with respect to intra-operative adjuncts designed to foster healing in the postoperative period, PuraGel, a RADA16 polypeptide hydrogel, was identified as an ECM-based solution, which aids in wound healing, adhesion prevention, and hemostasis at the completion of the case. In hydrogel format, this agent forms a synthetic matrix that serves as a scaffold for mucosal healing while serving as a mechanical barrier on tissue surfaces, thereby limiting scarring. To date, there have been no studies evaluating the role of this gel-based compound in the postoperative period in endoscopic skull base surgery.

Thus, amongst all of these agents that have been previously studied to some degree in patients undergoing endoscopic sinus surgery, there has been limited study on their role in endoscopic skull base surgery and utility in reducing sinonasal morbidity in the postoperative setting. Therefore, our goal was to investigate and compare the impact of varying sinonasal agents in the nasal cavity following endoscopic skull base surgery. We hypothesize that the absorbable, ECM-based gel compound (PuraGel) demonstrates an improvement on postoperative healing rate and sinonasal crusting with reduced patient morbidity and improved patient comfort when compared to non-absorbable agents.

This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group).

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery

Modified Lund-Kennedy nasal endoscopy score to rate mucosal edema, nasal crusting, and scarring. This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group). This scoring will address wound healing, adhesion formations. Scoring will be performed at 1 week, 4 weeks, and 12 weeks following surgery. The timing of these assessments is based on the routine postoperative follow-up schedule. No additional appointments will be made for the purposes of this study. We will be looking at the change in this score over time.

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Modified Lund-Kennedy nasal endoscopy score.

Patient-reported pain visual analog scale during postoperative debridement of the main nasal cavity. Minimum score is 1 (reflecting no pain) and the maximum score is 10 (reflecting extreme amount of pain).

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Patient-reported pain visual analog scale.

Postoperative, subjective QOL score with the validated Anterior Skull Base Nasal Inventory-12 (ASK-12) at 1 week, 4 weeks, and 12 weeks postoperatively.

Minimum would be 0. Maximum would be 72. Higher score means worse outcome. The un-abbreviated title is Anterior Skull Base Nasal Inventory-12.

Likert scale of mucosalization of the nasal septum graded by blinded reviewer via nasal endoscopy video

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Likert scale of mucosalization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Myriad™ Augmented Soft Tissue Reconstruction Registry	NCT05243966	Abdominal Wound... Necrotizing Sof... Lower Extremity... Pilonidal Sinus Anal Fistula Hidradenitis Su... Pressure Injury	Myriad Matrix™ ...	18 Years -	Aroa Biosurgery Limited
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery	NCT05898074	Skull Base Neop... Cerebrospinal F... Nasal; Hypertro...	Non-Absorbable ... PuraGel (RADA16...	18 Years -	Indiana University

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