Brijjit Device for Hypertrophic Scars

(FMTB Brij Trial)

Overseen By Carolyn Cafro, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Accutane, Steroids

Disqualifiers: Keloids, Radiation, Smoking, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Brijjit® device can reduce hypertrophic scars in individuals undergoing gender-affirming chest surgery. The device will be used on one side of the chest, while the other side will not, allowing for a direct comparison of scar outcomes. The study will assess both the appearance of scars and participants' perceptions of them. It is suitable for individuals undergoing double incision chest surgery who can adhere to the post-surgery instructions for using Brijjit®. Participants should not have a history of keloid scars or conditions that affect healing, such as certain autoimmune diseases or diabetes. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use certain medications like Accutane within the past year or chronic systemic steroids. If you are taking these, you may need to stop before participating.

What prior data suggests that the Brijjit device is safe for reducing hypertrophic scars?

Research shows that the Brijjit® device is generally easy for patients to use. Studies have found that Brijjit® can greatly reduce post-surgical wound complications, potentially aiding healing without major side effects.

Although specific side effects of Brijjit® are not listed in the available studies, the emphasis on reducing scarring without serious side effects is encouraging. If Brijjit® caused frequent or severe issues, research would likely mention it. Always consult a healthcare provider for personalized advice and consider all possible risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for hypertrophic scars, which often include silicone sheets, steroid injections, or laser therapy, the Brijjit device offers a new approach by physically supporting the incision site to minimize tension. Brijjit is applied immediately after surgery and remains in place for weeks, potentially reducing the formation of raised, thick scars by mechanically offloading stress from the healing skin. Researchers are excited about Brijjit because it offers a non-invasive and straightforward method to improve scar appearance, potentially enhancing both aesthetic outcomes and patient comfort during healing.

What evidence suggests that the Brijjit device is effective for reducing hypertrophic scars?

Research has shown that Brijjit® can help reduce scar formation. A study in the Aesthetic Surgery Journal found that Brijjit® reduced scar size by 38% and lowered the chance of wound problems by 90%. This results in smaller, less noticeable scars with fewer post-surgery issues. In this trial, participants will have Brijjit® applied to one side of their chest, while the other side will receive only standard care. The device uses special tissue bridges to control scar formation. This method reduces signals in the body that cause thick, raised scars and aids in better wound healing. Early clinical evidence supports Brijjit®'s ability to improve scar outcomes, making it a promising choice for minimizing scarring after surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Esther A Kim, MD

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

This trial is for individuals undergoing gender-affirming bilateral double incision mastectomies who want to reduce the risk of hypertrophic scarring. Participants will use Brijjit® on one side of their chest while the other side serves as a control with standard care.

Inclusion Criteria

I am willing to come back for follow-up visits and take part in study evaluations.

I am 19 years old or older.

I am planning to have a double incision mastectomy for gender affirmation.

Exclusion Criteria

Active smoker

I have had surgery on my chest or breast before.

Any other condition determined by PI to preclude subject from joining study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Initial application of Brijjit® is done intraoperatively, and participants continue Brijjit therapy until 6 weeks post-op

6 weeks

Initial application during surgery, follow-up at 2 weeks, and final visit at 6 weeks

Follow-up

Participants are monitored for scar characteristics and patient perception of scars

1 year

Regular follow-up visits up to 1 year post-op

What Are the Treatments Tested in This Trial?

Interventions

• Brijjit®

Trial Overview The study tests Brijjit® BP100-6 and BP-75 devices against normal wound dressing in preventing scars after surgery. It's a self-controlled trial where each patient's one chest side gets the device, and the other gets standard treatment.

How Is the Trial Designed?

Group I: Self-control Brijjit Application and Control Experimental Treatment 2 Interventions

The side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides. The control chest side will receive only standard of care and normal wound dressing.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07147166

Evaluating the Efficacy of Force Modulating Tissue Bridge ... We hypothesize that applying FMTBs to surgical incisions will improve scar outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing.

2. brijmedical.com brijmedical.com/introducing-brijjit-scar-therapy-from-brij-medical-help-prevent-bad-scars-before-they-form-with-brijjit/

Help Prevent Bad Scars Before They Form with Brijjit Holly Wall, published in the Aesthetic Surgery Journal, Brijjit has been shown to reduce scar area by 38% and decrease wound breakdown by 90%.

3. brijmedical.com brijmedical.com/wp-content/uploads/2023/11/Kenkel-et-al-Brijjit-RCT-Decreases-Wounds-and-Scars.pdf

Early Scar Analysis From a Randomiz In this study, we report clinical findings on postoperative wound healing and early scar formation from a randomized controlled trial in which the FMTB is used ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT05028816/Prot_SAP_000.pdf

Brijjit Protocol Version 6: May 22, 2024 1 of 17 TITLE The cumulative effect of these factors is increased scar burden, increased scar visibility, and an increased risk of pathological scars ( ...

5. brijmedical.com brijmedical.com/wp-content/uploads/2024/09/BRIJ-Medical-Scar-Therapy-Guide-.pdf

Your Practice's Guide to Brijjit Scar Therapy Big improvements for scars. Small changes to your practice. Backed by early clinical evidence demonstrating its effectiveness in reducing scars for.

6. brijmedical.com brijmedical.com/

BRIJ Medical: Home BRIJJIT is a force-modulating tissue bridge designed to Relieve the Tension to support beautiful healing for your patients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10902896/

Early Scar Analysis From a Randomized Controlled Trial This study provides evidence that the use of continuous mechanomodulation significantly reduces postoperative wound complications after skin closure.