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

Diseases and Abnormalities at or Before Birth

Immune System Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Eye Diseases

Blood and Lymph Conditions

Musculoskeletal Diseases

Mouth and Tooth Diseases

Rare Diseases

Dermatitis, Atopic

Dermatitis

Eczema

Multiple Sclerosis

Sclerosis

Kidney Diseases

Stroke

Diabetes Mellitus

Syndrome

Myasthenia Gravis

Asthma

Alzheimer Disease

Macular Degeneration

Lymphoma

Leukemia

Scleroderma, Systemic

Scleroderma, Diffuse

Heart Diseases

Anemia, Sickle Cell

Thalassemia

beta-Thalassemia

Psoriasis

Arthritis

Crohn Disease

Spondylitis

Parkinson Disease

Thyroid Diseases

Hepatitis A

Hepatitis

Liver Cirrhosis

Fibrosis

Schizophrenia

Hypersensitivity

Cystic Fibrosis

Autistic Disorder

Amyloidosis

Graves Disease

Colitis

Fibromyalgia

Myofascial Pain Syndromes

Colitis, Ulcerative

Spondylarthritis

Vasculitis

Vitiligo

Alopecia

Alopecia Areata

Celiac Disease

Spondylitis, Ankylosing

Behcet Syndrome

Hepatitis, Autoimmune

Pemphigus

Epilepsy

Epilepsies, Myoclonic

Anemia

Liver Diseases

Hepatitis, Viral, Human

Virus Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Joint Diseases

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Mental Disorders

Psychotic Disorders

Schizophrenia Spectrum and Other Psychotic Disorders

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Dementia

Tauopathies

Neurocognitive Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Pancreatic Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

The study may require a tissue collection and/or a participant survey for participation. Most tissue collected will come from a blood draw; up to 100mL for the health condition group, 60mL for the exceptive condition group, and up to 180mL for the control group (if determined safe for the participant). Participant surveys may involve participant reported outcomes (PROs) or custom participant surveys.

Specimen sample

Carolyn Bidwell

Houman Hemmati, MD

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.

Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results

Sanguine Biosciences

Necrosis

Acne Vulgaris

Abscess

Anti-Inflammatory Agents

Antirheumatic Agents

All Drugs and Chemicals

Adalimumab

Tumor Necrosis Factor Inhibitors

Adalimumab pre-filled syringe, administered by subcutaneous injection

adalimumab

AbbVie Inc.

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

HS is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria.

Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER (Open-Label Extension)

Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.

AbbVie (prior sponsor, Abbott)

TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.

Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555.

All Adalimumab

All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.

EW/EW/EW

All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.

EW/EOW/EW

All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.

EW/PBO/EW

All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.

PBO/EW/EW

Baseline characteristics provided by reporting groups defined by treatment received in the prior phase 3 studies, plus adalimumab every week (EW) received in M12-555. Baseline defined as the last measurement prior to the first dose of study drug in the prior phase 3 study (M11-810 or M11-310 for baseline characteristics.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives	NCT05635266	Age-Related Mac... Allergies Alpha-Gal Syndr... Alzheimer Disea... Amyloidosis Ankylosing Spon... Arthritis Alopecia Areata Asthma Atopic Dermatit... Autism Autoimmune Hepa... Behcet's Diseas... Beta-Thalassemi... Cancer Celiac Disease Kidney Diseases COPD Crohn Disease Cystic Fibrosis Diabetes Dravet Syndrome DMD Fibromyalgia Graves Disease Thyroid Disease... Hepatitis Hidradenitis Su... ITP Leukemia ALS Lupus or SLE Lymphoma Multiple Sclero... Myasthenia Grav... Heart Diseases Parkinson Disea... Pemphigus Vulga... Cirrhosis Psoriasis Schizophrenia Scleroderma Sickle Cell Dis... Stroke Ulcerative Coli... Vasculitis Vitiligo	Specimen sample	18 Years - 85 Years	Sanguine Biosciences
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa	NCT01635764	Hidradenitis Su...	adalimumab	18 Years -	AbbVie
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa	NCT01635764	Hidradenitis Su...	adalimumab	18 Years -	AbbVie
Safety and Efficacy of Laser Therapy in Gynaecology	NCT04073082	Herpes Genitali... Genital Wart Lichen Sclerosu... Cervical Intrae... Labial Reductio... Episiotomy Scar Bartholin Cyst Hidradenitis Su...		18 Years -	Juna d.o.o.

Spots Global Cancer Trial Database for hidradenitis suppurativa