Silk Bioprotein for Wound Healing

Overseen By Parhom Towfighi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Chronic steroids

Disqualifiers: Breast cancer, Breast surgery, Radiation, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate postoperative period

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.

Research Team

Ivan Hadad, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for individuals over 18 years old undergoing double-incision bilateral mastectomy for female-to-male gender affirmation surgery with the principal investigator, who must be a plastic surgeon in the IU Health system.

Inclusion Criteria

I am over 18 and planning a double-incision mastectomy for female-to-male transition with an IU Health system plastic surgeon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo double-incision mastectomy with one side dressed with Silk bioprotein and the other with Dermabond/Prineo

Surgery and immediate postoperative period

1 visit (in-person for surgery)

Follow-up

Participants are monitored for wound healing, MARSI, and other postoperative outcomes

12 weeks

Multiple visits (in-person and virtual) for assessments and surveys

Assessment

Blinded plastic surgeons evaluate postoperative photos for scar outcomes

12 weeks postoperative

Treatment Details

Interventions

• Silk Bioprotein

Trial Overview The study is testing Silk bioprotein as a post-surgical wound dressing against Dermabond/Prineo Dressing to see which is more effective for patients after double-incision mastectomy.

Participant Groups

Group I: Sylk Wound Dressing Experimental Treatment 1 Intervention

Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.

Group II: Dermabond/Prineo Dressing Experimental Treatment 1 Intervention

Patients who will be enrolled to this study will act as both the control and experimental group. This is a surgery that is done bilaterally for every patient. On one side of the body, the intervention dressing (Silk bioprotein) will be applied; on the other side of the body, the control dressing (Dermabond/Prineo) will be applied. All patients in the study are both in the control and experimental group given they act as their own controls.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+