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

Musculoskeletal Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Sarcoma

Myosarcoma

Muscle Neoplasms

Soft Tissue Neoplasms

Muscular Diseases

Quality of Life

Soft Tissue Sarcoma

Limb salvage

Erkki J Tukiainen, MD, PhD

Carl Blomqvist, MD, PhD

This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.

The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.

Patient hospital records are retrospectively reviewed for demographic and clinical data.

The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.

Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage

Functional Outcomes and Health Related Quality of Life in Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study

To assess health-related quality of life and upper-extremity functional capability

to assess the health-related quality of life

Tampere University Hospital

Helsinki University Central Hospital

Bone Neoplasms

Bone Diseases

Coagulants

All Drugs and Chemicals

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

At initiation of surgical preparation, participants randomized to the active treatment arm will receive tranexamic acid 10 mg/kg (max 1 g), given via syringe pump programmed to infuse over 15 minutes. If no unacceptable toxicities occur, a second dose of tranexamic acid IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).

At initiation of surgical preparation, participants randomized to the placebo treatment arm will receive 0.9% sodium chloride (salt water). It will be matched in appearance, volume, and administration to the active treatment arm with tranexamic acid. If no unacceptable toxicities occur, a second dose of placebo IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).

0.9% sodium chloride

Michael D. Neel, MD

This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a limb salvage procedure that frequently requires perioperative or post-operative transfusions of blood products.

Primary Objective

* To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg) for patients undergoing limb salvage procedures of the distal femur or proximal tibia who are randomized to receive perioperative tranexamic acid (TXA) versus placebo.

Secondary Objectives

* To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for patients randomized to receive perioperative TXA versus placebo.
* To evaluate differences in post-operative daily surgical drain output for patients randomized to receive perioperative TXA versus placebo.
* To evaluate changes in estimated blood loss (EBL) for patients randomized to receive perioperative TXA versus placebo.
* To evaluate the association between the intra-or post-operatively transfused blood volume and estimated blood loss (EBL) for patients randomized to receive perioperative TXA and placebo, respectively.

Exploratory Objectives

* To evaluate differences in functional outcomes post-operatively for patients randomized to receive perioperative TXA versus placebo.
* To explore if significant correlations are observed between parameters reported with rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric and young adult patients undergoing limb salvage procedure who are randomized to perioperative TXA versus placebo.
* To evaluate differences in the prevalence and management of wound complications such as superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post- operative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.

Eligible participants undergoing limb salvage procedures will be randomized to receive either tranexamic acid (TXA) or placebo peri-operatively.

The initial dose of tranexamic acid/placebo will be given at the initiation of surgical preparation. The second dose will be given 6 hours after the first dose (either intraoperatively or post-operatively). All doses will be given intravenously. Doses will be double blinded and randomized for each surgical procedure.

To allow for the study team and participants to remain blinded to the treatment assignment, the study drug will be labeled as Tranexamic Acid/Placebo (TXAKIDS) followed by applicable dose and administration instructions.

Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure

Tranexamic Acid (TXA) to Reduce Volume Of Blood Transfused In Pediatric And Young Adult Cancer Patients Undergoing Limb Salvage Procedure Of A Lower Extremity

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

The intra-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.

The post-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.

Summary statistics will be provided for the changes in platelet level from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.

Summary statistics will be provided for the decline in hemoglobin from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.

Summary statistics will be provided for postoperative daily surgical drain output (in milliliters per 24 hour period for the duration of the drain) for each group. The group difference will be compared using two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.

The EBL for pre-op to post-op level, for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The EBL of the two groups (TXA vs. Placebo) will be evaluated using a two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data.

Regression model will be used to access the correlation between the log transformed intra-or post-operatively transfused blood volume and EBL.

St. Jude Children's Research Hospital

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

This study aims to:

1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
2. assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.

The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps.

Patient hospital records are retrospectively reviewed to chart the demographic and clinical data.

The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.

Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study

Assessment of health-related quality of life

Health-related quality of life assessment

Functional assessment of the reconstructed limb

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
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage	NCT02380651	Cancer of Muscl...	Limb salvage	18 Years - 100 Years	Helsinki University Central Hospital
Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure	NCT04410042	Cancer of the B... Limb Salvage	Tranexamic Acid 0.9% sodium chl...	- 24 Years	St. Jude Children's Research Hospital
Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage	NCT02536053	Limb Salvage	Limb salvage	10 Years -	Helsinki University Central Hospital

Spots Global Cancer Trial Database for limb salvage

Every month we try and update this database with for limb salvage cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.