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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Silk bioprotein as a wound dressing for individuals undergoing double-incision mastectomy as part of female-to-male gender affirmation surgery. The study compares this new dressing to a standard one, with each patient using Silk bioprotein on one side of the chest and the standard dressing on the other. Eligible candidates are those scheduled for this specific surgery who have not had past breast cancer or surgery. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical care for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Silk bioprotein is safe for wound healing?

Research has shown that silk bioprotein is safe for use as a wound dressing. One study found it reduced issues like pain and skin rash after surgery. Another study confirmed that silk bioprotein does not cause skin irritation or toxicity. The FDA has already approved this dressing, indicating it has been checked for safety. Overall, evidence suggests that patients tolerate silk bioprotein well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using silk bioprotein for wound healing because it offers a unique approach by harnessing natural proteins. Unlike traditional dressings such as Dermabond or Prineo, which primarily serve as barriers, silk bioprotein might actively promote healing due to its biocompatibility and ability to support cell growth. This innovative use of silk could lead to faster healing times and improved outcomes, making it an attractive alternative to existing options.

What evidence suggests that Silk Bioprotein is effective for wound healing?

Research has shown that silk bioprotein dressings can effectively heal wounds. One study significantly reduced post-surgery complications with these dressings. Another study found that wounds healed faster with silk dressings compared to other types. In this trial, participants will receive both the silk bioprotein dressing and the control dressing (Dermabond/Prineo) on different sides of their body, allowing for direct comparison. These dressings are safe and compatible with the body, helping to reduce issues like skin injuries from medical tape. Overall, silk bioprotein dressings appear promising for improved healing in surgical wounds. ^{1 5 6 7 8}

Who Is on the Research Team?

Ivan Hadad, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10603584/

Silk Bioprotein as a Novel Surgical-Site Wound Dressing The use of a silk bioprotein wound dressing significantly reduces the incidence of MARSI throughout the postoperative period.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0883540325008228

Silk Fibroin Wound Dressing Significantly Decreases ... Delayed wound healing was 0% with silk dressings compared to 4.9% with mesh dressings (P = 0.12, Table 2). Delayed wound healing was found in ...

3. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2024/12000/superiority_of_a_silk_surgical_site_wound_closure.19.aspx

Superiority of a Silk Surgical Site Wound Closure Device... Conclusion: A silk fibroin wound dressing significantly reduces the incidence of wound-healing complications throughout the postoperative period. CLINICAL ...

4. trialx.com trialx.com/clinical-trials/listings/316862/silk-bioprotein-as-a-wound-dressing-for-double-incision-mastectomy/

Silk Bioprotein as a Wound Dressing for Double-Incision ... Silk bioprotein dressings have shown promise due to their biocompatibility and regenerative properties, potentially reducing MARSI compared to ...

5. nature.com nature.com/articles/s41598-025-88150-w

A prospective multicenter phase III clinical trial evaluating ... This study concluded that silk elastin sponges may be an effective new option for wounds that are unresponsive to existing treatments. Trial ...

6. dermatologyadvisor.com dermatologyadvisor.com/news/silk-bioprotein-wound-dressing-reduces-adhesive-related-skin-injury-incidence/

Silk Bioprotein Wound Dressing Reduces Medical ... An experimental silk bioprotein wound dressing significantly reduced postoperative wound discomfort, rash, and medical adhesive-related skin ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3052577/

Safety Evaluation of Silk Protein Film (A Novel Wound ... It could be concluded from the present study that the test materials used in the study are safe under acute dermal toxicity, acute dermal irritation and skin ...

8. academic.oup.com academic.oup.com/asjopenforum/article-abstract/doi/10.1093/asjof/ojad071/7238111

Silk Bioprotein as a Novel Surgical-Site Wound Dressing This study aimed to assess the efficacy and safety of a silk bioprotein wound dressing compared to the Dermabond Prineo (Ethicon, Inc., Somerville, NJ) skin ...