Clinical Trials

The Department of Plastic Surgery is conducting clinical trials in the areas of nerve repair, osteoarthritis of the knee. All trials are managed through the Center for Innovation in Restorative Medicine (CIRM).

Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

Brief Title: Autologous Fresh Fat Grafting Followed by Autologous Cryopreserved Fat Grafting

NCT Number: NCT06747715

Protocol ID: STUDY24080145

The goal of this clinical trial is to validate the safety and effectiveness of a two-stage approach for minimally invasive craniofacial soft tissue reconstruction using autologous fat grafting in wounded service members, veterans and civilians.

The main questions it aims to answer are:

1. Will treating subjects with post-traumatic craniofacial deformities using fresh fat grafts, followed by a second treatment 3 months later with cryopreserved fat stored at -80°C, improve facial tissue regeneration and appearance?

2. How do volume retention and tissue health change between fresh and cryopreserved grafts in humans?

3. How do factors such as cellular composition of the graft, patient demographics, and medical conditions (including diabetes, tobacco use, medications, age, and BMI) affect fat graft volume retention and overall outcomes?

Researchers will compare results from the second-stage cryopreserved fat grafting to fresh fat grafting to assess outcomes like volume retention, patient recovery, and cost reduction.

Participants will:

    Undergo an initial fat grafting procedure.

    Have additional fat harvested and cryo-stored for use in a second-stage procedure.

    Receive the cryopreserved fat in a later stage without the need for a second fat harvest.

    Receive small test injections behind each ear for later analysis.

    Provide data on demographics and medical conditions for correlation with outcomes.

Autologous Point-of-Care Adipose Therapy: Recent Injury

Brief Title: Autologous Point-of-Care Adipose Therapy: Recent Injury (Aim 1)

NCT Number: NCT06857448

Protocol ID: STUDY24080150 - Recent Injury

The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss.

The main question it aims to answer are:

- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction?

Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk.

Participants will:

- Receive immediate fat grafting into the wound.

- Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

 

Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

Brief Title: Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar (Aim 2)

NCT Number: NCT06857435

Protocol ID: STUDY24080150 - Delayed Injury

The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss.

The main question it aims to answer are:

- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture?

Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk.

Participants will:

- Receive fat grafting at time of scar revision.

- Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

PramStat Patch Pivotal Study

Brief Title: PramStat Patch Pivotal Study

Protocol ID: SLX-23-001

Prospective, Randomized, Controlled, Multicenter, Pivotal, Single-blind Clinical Investigation Evaluating the Safety and Effectiveness of the PramStat Sealant Patch for Hemostasis During Abdominopelvic Surgeries.  The study seeks to assess whether the PramStat Sealant Patch (“PramStat Patch”) can safely and effectively control bleeding as well as (i.e., is non-inferior to) a standard hemostatic control, absorbable gelatin sponge USP (e.g., SURGIFOAM®, Ethicon US, LLC) with thrombin).

Melodi Matrix™ in Breast Reconstruction

Brief Title: Melodi Matrix™ in Breast Reconstruction

NCT Number: NCT06027996

Protocol ID: 01-2023

Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction with Infection Outcomes Assessment (“ARIA Trial”).  This study seeks to assess the safety and effectiveness of the Melodi Absorbable Antibacterial Matrix for soft tissue support in immediate, two-stage post- mastectomy alloplastic prepectoral breast reconstruction.

Currently Recruiting

Penile Lengthening Pre-Penile Prosthesis Implantation

Brief Title: Penile Lengthening Pre-Penile Prosthesis Implantation

NCT Number: NCT07053826

Unique Protocol ID: STUDY24110037

The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX, prior to implantation of a penile prosthesis, can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.