Clinical trials: Acellular Dermal Matrix in Breast Reconstruction
Implant Based Breast Reconstruction
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
- Trial name
- SHAPE (NCT06797258)
- Testing
- FlexHD® Pliable, No intervention
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Musculoskeletal Transplant Foundation
Breast Cancer, Breast Carcinoma in Situ
Immediate Breast Reconstruction With Acellular Dermal Matrix
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique.
- Conditions
- Breast Cancer, Breast Carcinoma in Situ, Mammaplasty, Acellular Dermis
- Trial name
- NCT04209010
- Testing
- one-stage technique
- Volunteers
- 44 people
- Sponsor
- Aarhus University Hospital
Pre-Pectoral Breast Reconstruction Following Mastectomy
Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
- Trial name
- NCT06853964
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- AlloSource
Breast Cancer
Use of Dermal Matrix in Breast Reconstruction
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
- Trial name
- NCT00692692
- Testing
- DermaMatrix, standard of care tissue expander breast reconstruction surgery after mastectomy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Vanderbilt University
Breast Cancer Female
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other…
- Trial name
- SCderm (NCT06553859)
- Testing
- No intervention conducts.
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- DOF Inc.
Breast Cancer, Pain, Postoperative
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast…
- Conditions
- Breast Cancer, Pain, Postoperative, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- NCT01591746
- Testing
- Botulinum Toxin Type A
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Breast Implant; Complications, Breast Implant Infection
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
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…
- Conditions
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture, Breast Seroma
- Trial name
- RTADM (NCT06139588)
- Testing
- acellular dermal matrix implant for breast reconstruction
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- European Institute of Oncology
Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or…
- Trial name
- NCT02562170
- Testing
- TiLoop Bra, Protexa
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Breast Reconstruction Following Mastectomy
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data…
- Trial name
- NCT05031962
- Testing
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Where
- 10 sites in France
- Volunteers
- 112 people
- Sponsor
- Meccellis Biotech
Breast Cancer
Biological Matrices Versus Synthetic Meshes
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months.
- Trial name
- BIOSYM (NCT05449691)
- Testing
- One-stage immediate breast reconstruction
- Where
- 5 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Breast Cancer
Dermacell ADM Without Basement Membrane
DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable…
- Trial name
- NCT03667560
- Testing
- Dermacell ADM without basement membrane, FlexHD
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Virginia
Breast Cancer
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction.
- Trial name
- NCT01679223
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Nevada, Las Vegas
Breast Cancer
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
- Trial name
- NCT02061527
- Testing
- Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 135 people
- Sponsor
- Karolinska University Hospital
Breast Cancer Female, Breast Reconstruction
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
- Trial name
- SCderm (NCT06555692)
- Testing
- Transplant acellular dermal matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Breast Cancer, Mastectomy
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.
- Trial name
- NCT01781299
- Testing
- AlloDerm RTU, SurgiMend PRS
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Pittsburgh
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
Breast Cancer Female, Breast Reconstruction
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been…
- Trial name
- ADM (NCT06555614)
- Testing
- Acellular Dermal Matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Breast Neoplasms, Mammaplasty
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use.
- Conditions
- Breast Neoplasms, Mammaplasty, Acellular Dermis
- Trial name
- NCT03744273
- Testing
- breast capsule biopsy
- Where
- South Korea
- Sponsor
- Samsung Medical Center
Acellular Dermal Matrix in Breast Reconstruction
Comparing AlloDerm and DermACELL in Breast Reconstruction
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.
- Trial name
- NCT04710537
- Testing
- AlloDerm, DermACELL
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins University
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell