Infections

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Wounds and Injuries

Breast Neoplasms

Communicable Diseases

Contracture

Seroma

Implant Capsular Contracture

Joint Diseases

Muscular Diseases

Inflammation

Foreign Bodies

Foreign-Body Reaction

Prosthesis Failure

Postoperative Complications

Native adm used in the setting of mastectomy and implant reconstruction after QUART

Veritas adm used in the setting of mastectomy and implant reconstruction after QUART

Native adm used in the setting of expander removal and implant positioning after mastectomy + RT

Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT

Native adm used in the setting of implant exchange after mastectomy + RT

Veritas adm used in the setting of implant exchange after mastectomy + RT

Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction

Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction

acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy

acellular dermal matrix implant for breast reconstruction

Andrea Vittorio Emanuele Lisa, MD

The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)

The main questions the study aims to answer are:

* is one of the two matrices better than the other? (better results with fewer complications)
* is there a group of patients who benefit more than another from the use of this type of devices?
* is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices.

Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.

Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).

female patients undergoing breast reconstruction after mastectomy

Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction

Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction

Is there a type of dermal matrix that performs better than the other in a specific subgroup of patients?

Does one dermal matrix perform better than the other in terms of efficacy and complication rates?

Is there a subgroup of patient where the use of ADM proves more beneficial than others?

European Institute of Oncology

Breast Diseases

Skin Diseases

Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).

SurgiMend® PRS

No Intervention

This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.

SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy

Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy

Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange

No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p.

Increase in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture.

Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)

Time to Completion (expand-to-implant exchange)

Procedural Attributes: Total number of OR procedures

Procedural Attributes: Total number of ("in office" and OR procedures)

Integra LifeSciences Corporation

Behaviors and Mental Disorders

Diseases and Abnormalities at or Before Birth

Mouth and Tooth Diseases

Rare Diseases

Depression

Syndrome

Congenital Abnormalities

Parotid Neoplasms

Sweating, Gustatory

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Parotid Diseases

Salivary Gland Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Hyperhidrosis

Sweat Gland Diseases

Frey's Syndrome

Oral Cancer

29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation

41 patients (control group) had a total parotidectomy alone

Wen Luo, DMD

The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy.

Seventy patients who underwent total parotidectomy were selected for inclusion in the study. We analyzed 41 cases of total parotidectomy (control group) and 29 cases of simultaneous ADM implantation following total parotidectomy (ADM group) for infraauricular depressed deformities and the presence of gustatory flushing or sweating. The follow-up periods ranged from 6 months to 7 years.

The Results showed facial contours and bilateral symmetry improved after surgery in the ADM group. In the control group, an infraauricular depressed deformity was evident in all 41 cases. Frey's syndrome was recorded in one patient (3.4%) from the ADM group and 14 patients (34.1%) from the control group. No cases of immune rejection, infection, hematoma, or salivary fistula were observed in either group.

The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome

The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy

to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy

West China Hospital

West China Hospital of Stomatology

Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.

Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.

If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

Reconstruction with ADM.

Mastectomy for invasive or pre-invasive breast cancer

Skin or nipple sparing mastectomy

Immediate breast reconstruction with implant

Reconstruction with implant

Implant based breast reconstruction with total submuscular coverage

Total submuscular coverage

Implant based breast reconstruction with partial submuscular coverage

Partial submuscular coverage

Fredrik Lohmander, MD

To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.

OBJECTIVES: To evaluate the outcome of immediate breast reconstruction with Acellular Dermal Matrix (Strattice™), measuring safety, effectiveness, and costs. The primary outcome measure is number of unplanned surgical procedures.

STUDY DESIGN: A prospective randomized multicenter trial. One hundred and twenty patients with breast cancer will be enrolled into the study. Study duration will be two years from time of primary cancer surgery.

TRIAL DESIGN This is a randomized controlled multicenter trial, comparing IBR without (group A) and with (group B) the use of ADM. Participants eligible for the study are patients with breast cancer, planned for mastectomy, who wishes IBR with implants. Each participant is individually randomized to either be reconstructed using implants with total submuscular coverage (A) or reconstruction with ADM and partial muscle coverage (B).

Method of assigning patients to treatment groups:

After signing and dating the informed consent the patient is entered into the study. If all inclusion and none of the exclusion criteria are full filled, the patient will be randomized to group A or group B.

TREATMENT/ INTERVENTION The decision and treatment plan advocating mastectomy is based on multi disciplinary conference (MDT), and the diagnosis of invasive or pre-invasive (in situ) breast cancer is made on triple assessment. If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

Randomization at enrollment is made with regard to the use of ADM or not, so both expander and direct-to-implant techniques will be utilized in both groups, depending on the quality of skin flaps at time of surgery.

RANDOMIZATION TYPE Patients will be allocated to treatment according to permuted block technique. The actual randomization will be performed using computer based system located at Regional Cancer Center (RCC) within Karolinska Institutet. In this system inclusion and exclusion criteria will be automatically checked before patients are randomized to treatment. The randomization process will be stratified for the participating units.

STATISTICAL METHODS The main endpoint to be analyzed is the proportion of unplanned reoperations after the initial breast reconstruction. The difference in proportions between the two groups will be presented as a difference in proportion together with a 95% confidence interval. Differences will be tested using Fishers Exact Test. Logistic regression will be used to take into account possible confounding factors.

STUDY MANAGEMENT Data recording: The investigators will ensure that all data from patient visits are entered promptly in ink, in the case report forms (CRF). The principal investigator must sign the final CRF page to attest to the accuracy and completeness of the data. The data from the CRFs are then transferred to a database.

Monitoring and audit: At periods not exceeding 3 months, centers will be contacted to discuss the progress of the trial, with the purpose to verify CRF data against source records for accuracy of data recording and collection.

Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study

Follow-up time after primary surgery is 24 months.

To measure aesthetic outcome between the two study groups using a 6- point scale. The evaluation will be done by three independent groups consisting of lay people, professionals (breast/ plastic surgeons) and patient evaluation. The aesthetic evaluation will be based on the pre and postoperative photos.

To measure any difference between the two study groups in complication rates.

To compare the total number of surgical procedures (planned or unplanned) between the two study groups).

A cost-benefit analysis comparing the cost for an IBR with implant without ADM, vs. IBR with ADM (Strattice™) during a 24 months follow-up time.

Measure Quality of Life in both groups, using the EORTC QLQ-C30 (Generic tool), EORTC-BR23 (Breast cancer specific tool), EORTC-BRR (Specific for breast reconstruction).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction	NCT06139588	Breast Implant;... Breast Implant ... Implant Capsula... Breast Seroma Breast Implant ... Breast Cancer	acellular derma...	-	European Institute of Oncology
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy	NCT01959867	Breast Cancer	SurgiMend® PRS No Intervention	18 Years -	Integra LifeSciences Corporation
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy	NCT01959867	Breast Cancer	SurgiMend® PRS No Intervention	18 Years -	Integra LifeSciences Corporation
The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome	NCT01414790	Parotid Tumor	ADM	10 Years - 79 Years	West China Hospital
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment	NCT02061527	Breast Cancer	Reconstruction ... Skin or nipple ... Reconstruction ... Total submuscul... Partial submusc...	18 Years -	Karolinska University Hospital
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy	NCT01959867	Breast Cancer	SurgiMend® PRS No Intervention	18 Years -	Integra LifeSciences Corporation

Spots Global Cancer Trial Database for adm

Every month we try and update this database with for adm 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.

Spots Global Cancer Trial Database for adm

Every month we try and update this database with for adm 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.

Every month we try and update this database with for adm 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.