ClinicalTrials.gov ID: NCT04051242
Title: Enhanced Bioscaffold for Volumetric Muscle Loss (MTEC VML)
PI: J. Peter Rubin, MD
Description: We propose in this project to use XENMATRIX™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The graft has an antibiotic coating, specifically, Rifampin and Minocycline. This coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not yet been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated and will need further investigation. This trial proposes to test the applicability and utility of XENMATRIX™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma. Prior to Graft implantation, subjects will receive a pre-operative course of physical therapy for a maximum time period of 16 weeks. A physical therapist will confirm that functional plateau is reached prior to implantation of the Graft. Following Graft implantation, radiographic, functional, and electro physiotherapy outcomes will be measured at various time points up to 22-30 weeks post-operatively. A CT scan or MRI will be collected at the screening visit to evaluate tissue volume, then again at post-operative Visit 5. Physical therapy training will be performed as a research procedure following graft implantation for a maximum of 30 weeks. Additionally, physical therapy evaluations will be conducted at screening, pre-op visit 1, post-op visits 1, 2, 3, 4 and 5. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to graft implantation (Operative visit, Visit 3 and at Visit 5).
Primary & Secondary Objectives: The primary objective of the study is to assess the ability of XENMATRIX AB™ Surgical Graft to restore both function and mechanical strength.
The secondary objectives are 1) to assess the rate of infection in the use of the XENMATRIX AB™ Surgical Graft and 2) to examine the histologic properties of the biopsy tissue material in each subject for future correlation with clinical outcomes.
Measurement/Outcomes:
Primary endpoint:
Assessment of patient extremity function and mechanical strength post implantation of XENMATRIX AB™ Surgical Graft; after skeletal muscle injury.
Secondary endpoints:
- Patient rate of infection with the use of XENMATRIX AB™ Surgical Graft;
- Examination of histological properties of the biopsy tissue material in each subject for future correlation with clinical outcomes.
Numbers of subjects to undergo intervention: 10
For more information, please contact:
Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM
Director, Operations and Administration
Center for Innovation in Restorative Medicine (CIRM)
University of Pittsburgh, Department of Plastic Surgery
6B Scaife Hall, room 664
3550 Terrace Street
Pittsburgh, PA 15261
Phone: 412-648-9207
simonpa@upmc.edu