Silk Fibroin Dressings for ACL Reconstruction

Overseen By Layne Estes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Corticosteroids, Chemotherapy

Disqualifiers: Dermatologic conditions, Immunocompromised, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if silk fibroin dressings can reduce skin problems, such as rashes or blisters, after ACL (a knee ligament) surgery compared to the usual closure method. Participants will receive either the silk dressing or the standard adhesive closure (cyanoacrylate mesh closure) to assess differences in skin reactions. The trial seeks individuals undergoing ACL surgery who have no skin issues near the surgery site and have not recently used tobacco. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that silk fibroin dressings are generally safe. Studies exploring various medical applications have found that silk fibroin integrates well with the body, typically avoiding issues like allergic reactions. Tests on animals, such as rabbits, demonstrated good long-term healing results.

Cyanoacrylate mesh closures are also widely used and considered safe. They often close wounds in surgeries and rarely cause major problems. While some individuals might experience minor skin irritation, serious issues are uncommon.

Overall, evidence supports the safety of both treatments in this trial. Silk fibroin dressings show promise, and cyanoacrylate is already widely used in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about silk fibroin dressings for ACL reconstruction because they offer a unique blend of biocompatibility and strength, derived from natural silk, which can promote better healing. Unlike standard cyanoacrylate-based closure systems like Dermabond® or Prineo®, silk fibroin dressings are designed to integrate more naturally with the body, potentially reducing inflammation and scarring. Additionally, this treatment provides flexibility in managing bilateral procedures, as it can be applied alongside traditional methods to compare healing outcomes directly. This innovative approach could lead to improved recovery experiences for patients undergoing ACL surgeries.

What evidence suggests that this trial's treatments could be effective for reducing postoperative skin complications in ACL reconstruction?

Research has shown that silk fibroin dressings, one of the treatments studied in this trial, can help reduce skin problems like allergic reactions and blisters after surgery. Studies indicate that silk fibroin's strength and stability help protect surgical areas. Its biocompatibility means it works well with the body and is less likely to cause irritation or allergies. Early results suggest it is effective and safe for patients undergoing ACL (anterior cruciate ligament) surgery. While more research is needed, initial findings are promising for using silk fibroin in surgical dressings. Participants in this trial may receive silk fibroin dressings, while others will receive standard closure dressings using cyanoacrylate-based systems. ^{1 3 5 6 7}

Who Is on the Research Team?

Eric J. Strauss, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals undergoing anterior cruciate ligament (ACL) reconstruction. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed inclusion and exclusion requirements.

Inclusion Criteria

I am between 14 and 60 years old.

I am scheduled for ACL surgery.

I am over 18 and can consent, or if 14-17, I have parental permission.

Exclusion Criteria

I do not have an active infection.

I do not have skin conditions like eczema near my surgery area.

I am not immunocompromised due to conditions like uncontrolled HIV or ongoing treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either silk fibroin adhesive incision dressing or standard cyanoacrylate-based closure following ACL reconstruction

Immediate postoperative period

Follow-up

Participants are monitored for skin complications and comfort, itch, rehabilitation interference, and satisfaction using VAS and other scales

4-6 weeks

Follow-up 2 (4-6 weeks postoperatively)

Extended Follow-up

Participants' scar quality is assessed using POSAS approximately 4-6 months postoperatively

4-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cyanoacrylate Mesh Closure
• Silk Fibroin Incision Dressings

Trial Overview The study is testing two types of dressings used after ACL surgery: one made from silk fibroin and another using a cyanoacrylate-based closure system. The goal is to see which dressing leads to fewer skin complications like rashes, blistering, or redness post-surgery.

How Is the Trial Designed?

Group I: Silk fibroin adhesive incision dressing Experimental Treatment 1 Intervention

Participants will receive the silk fibroin adhesive incision dressing following anterior cruciate ligament reconstruction (ACLR).

Group II: Bilateral procedures Experimental Treatment 2 Interventions

For bilateral procedures (contralateral patellar tendon harvest for autograft), a within-subject design will be employed: one incision site will receive silk fibroin and the other cyanoacrylate, with side assignment randomized.

Group III: Standard closure dressing Active Control 1 Intervention

Participants will receive the standard-of-care incision management currently used in ACL reconstruction at NYU Langone Orthopedic Surgery, consisting of cyanoacrylate-based closure systems (e.g., Dermabond® or Prineo®) as determined by the operating surgeon.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/a52f0268d6004cc8/nct07217613-silk-fibroin-dressings-acl-reconstruction-biocompatible

Prospective Evaluation of Silk Fibroin Incision Dressings in ... The purpose of this study is to compare the incidence of early postoperative skin complications including allergic contact dermatitis, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10571837/

Could an Anterior Cruciate Ligament Be Tissue ... Silk grafts demonstrate superior mechanical performance and long-term stability, making them attractive for anterior cruciate ligament (ACL) tissue engineering.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214031X25001366

Artificial ligaments in anterior cruciate ligament reconstruction This review provides a comprehensive overview of the coatings used for ligaments, highlighting the promising role of surface modification in enhancing implant ...

4. withpower.com withpower.com/trial/phase-anterior-cruciate-ligament-reconstruction-9-2025-e10ae

Silk Fibroin Dressings for ACL Reconstruction ... Silk Fibroin Incision Dressings will have tolerable side effects & efficacy for patients with Anterior Cruciate Ligament Reconstruction. Learn more about the

5. researchgate.net researchgate.net/publication/383853939_Assessment_of_the_advantages_and_limitations_of_an_innovative_silk_fibroin_scaffold_for_the_reconstruction_of_the_anterior_cruciate_ligament_with_preclinical_in_vitro_and_in_vivo_evaluations

Assessment of the advantages and limitations ... Assessment of the advantages and limitations of an innovative silk fibroin scaffold for the reconstruction of the anterior cruciate ligament with preclinical in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39276659/

Assessment of the advantages and limitations ... This study aimed to assess the biocompatibility and integration of a silk fibroin textile prosthesis (SF-TP) with peri-implant bone tissue and ...

7. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1381838/pdf

Silk fibroin-based scaffolds for tissue engineering Shen et al. investigated the long-term repair effect of silk-collagen scaffolds in a rabbit model of anterior cruciate ligament injury.