Important Disclosure: The studies below describe uses of SYLKE® Adhesive Wound Closure that may include comparisons or applications not specifically addressed in FDA-required labeling. The safety and effectiveness of any such use(s) have not been established by FDA review. SYLKE® Adhesive Wound Closure is indicated for approximation of the skin edges of wounds from surgical incisions or simple, thoroughly cleansed, lacerations. For complete labeling including contraindications, warnings, precautions, and adverse events, see sylke.com/ifu. Study summaries presented on this page were developed by Sylke, Inc. and are provided alongside each source publication for reference. These summaries do not replace the full peer-reviewed publication.
Peer-Reviewed Clinical Data
"Six Evidence-based Recommendations for Perioperative Incisional Care in Plastic Surgery: A Narrative Review"
Narrative Review · PRS Global Open · 2025
Rouhani DS, Zeng S, Khoo KH, Ma M, Bishop SN, Janis JE, Mofid MM. Plast Reconstr Surg Glob Open. 2025.
Study Design: Narrative review examining current evidence-based practices for perioperative incisional care in class 1 clean wounds within plastic surgery.
Sample Size: Not applicable (review article synthesizing existing literature).
Primary Endpoint: Not applicable. The review synthesized six evidence-based recommendations for incisional care.
Key Results: The review examined current evidence across wound closure techniques, dressing selection, and perioperative skin management. Specific recommendations are detailed in the full publication.
Adverse Events: Not applicable (review article).
Limitations: Narrative review, not a systematic review or meta-analysis; subject to selection and interpretation bias inherent in the narrative review format; recommendations reflect the authors' synthesis of available evidence.
Author Disclosure: M. Mark Mofid, MD, FACS, is the founder and CEO of Sylke, Inc. Full conflict-of-interest disclosures for all authors are available in the publication.
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This summary was developed by Sylke, Inc.
"Silk Fibroin Wound Dressing Significantly Decreases Hypersensitivity Compared to 2-Octyl Cyanoacrylate Mesh Dressing"
Retrospective Cohort Study · The Journal of Arthroplasty · 2025
Aastroem KIM, Sarpong NO, Neuwirth AL, Cooper HJ, Geller JA, Shah RP. J Arthroplasty. 2025;doi:10.1016/j.arth.2025.06.071.
Study Design: Retrospective, single-surgeon cohort study at Columbia University Irving Medical Center.
Sample Size: N = 261 consecutive total joint arthroplasty patients (silk fibroin: n=58; 2-octyl cyanoacrylate mesh: n=203). Included TKA, THA, UKA, and revision TKA/THA.
Primary Endpoint: Hypersensitivity, delayed wound healing, wound edge separation, reoperations within 90 days, dressing application time, and cost.
Key Results: Hypersensitivity was 0% (0/58) in the silk group vs. 9.9% (20/203) in the mesh group. Delayed wound healing was 0% silk vs. 4.9% mesh (P = 0.12, not statistically significant). No wound edge separation with silk. Average cost savings of $465.91 per case with silk. Silk eliminated an average 3.7 minutes of OR time by removing the glue-drying step.
Adverse Events: No hypersensitivity, wound edge separation, or delayed wound healing in the silk group. Hypersensitivity occurred in 9.9% of the mesh group.
Limitations: Retrospective design; single-surgeon, single-center; non-randomized; unequal group sizes (58 vs. 203); silk group had no revision cases while mesh group included revisions; results may not be generalizable.
Author Disclosure: One or more of the authors have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to the DOI link. No authors were employees of, consultants to, or received compensation from Sylke, Inc. in connection with this work.
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This summary was developed by Sylke, Inc.
"Silk Fibroin Closure Eliminates the Incidence of Allergic Contact Dermatitis Compared to Cyanoacrylate Mesh in Total Joint Arthroplasty"
Retrospective Cohort Study · Arthroplasty Today · 2025
Moo Young JP, Deshpande VA, Porter S, Quilligan EJ, Scudday T, Barnett S, Gorab R. Arthroplast Today. 2025;33:101668.
Study Design: Retrospective cohort study at Hoag Orthopaedic Institute, a high-volume orthopaedic specialty hospital in Irvine, CA.
Sample Size: N = 257 total joint arthroplasty patients (cyanoacrylate mesh: n=172; silk fibroin: n=85). All TJAs from January 2019 to April 2024 with at least 6 weeks of follow-up.
Primary Endpoint: Incidence of allergic contact dermatitis (ACD) and wound complications between cyanoacrylate mesh (CM) and silk fibroin (SF) dressings.
Key Results: ACD was 6.4% in the CM group vs. 0% in the SF group (P = .018). No significant differences in other clinical outcomes between groups.
Adverse Events: No ACD or wound-related complications in the silk fibroin group.
Limitations: Retrospective design; single-center; non-randomized; historical comparison across a multi-year period (January 2019 to April 2024); dressing availability and surgical technique may have evolved during the study period; unequal group sizes. This article has a published correction (Arthroplast Today. 2025;33:101733).
Author Disclosure: R. Gorab received royalties from and is a paid consultant for DePuy Synthes Products, Inc. S. Barnett received royalties from and is a paid consultant for DePuy Synthes Products, Inc. and OMNIlife science, Inc. S. Porter and T. Scudday are paid consultants for Medical Device Business Services, Inc. and/or OMNIlife science, Inc. All other authors declare no potential conflicts of interest. Full disclosure statements are available in the publication. No authors were employees of, consultants to, or received compensation from Sylke, Inc. in connection with this work.
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This summary was developed by Sylke, Inc.
"Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings"
Prospective RCT · Plastic & Reconstructive Surgery · 2024
Rouhani DS, Singh NK, Chao JJ, Almutairi A, Seradj MH, Badowski-Platz R, Toranto JD, Mofid MM. Plast Reconstr Surg. 2024;154(6):1233-1244.
Study Design: Prospective, randomized, single-blinded, split-body clinical trial. Each patient served as their own internal control with silk dressing on one side and 3M Steri-Strips on the contralateral side. A combined 75-patient analysis pooled results with the prior Dermabond Prineo trial.
Sample Size: N = 50 (abdominoplasty, reduction mammaplasty, brachioplasty). Combined analysis: N = 75.
Primary Endpoint: Erythema, skin irritation, skin discomfort, need for pharmaceutical intervention, wound dehiscence, and mechanical skin injury.
Key Results: 20.8% of patients (10/48) had surgeon-assessed erythema scores of 7-10 on the Steri-Strip side vs. 0% (0/48) on the silk side (P = 0.002).
Adverse Events: No serious adverse events on the silk dressing side. Skin irritation requiring pharmaceutical intervention was reported on the Steri-Strip side; specific rates are in the full publication.
Limitations: Single-center; single-blinded (investigators not blinded); split-body design limits generalizability; procedures limited to plastic surgery body-contouring cases; combined 75-patient analysis pools data from two studies with different comparators. Registered at ClinicalTrials.gov (NCT05508945).
Author Disclosure: M. Mark Mofid, MD, FACS, has a financial interest in US patents 11,311,641 and 11,583,607, which describe animal bioprotein scaffold wound dressings. The other authors have no conflicts of interest with respect to the research, authorship, or publication of this article. No funding was received from any agencies in the public, commercial, or not-for-profit sectors. M. Mark Mofid, MD, FACS, is the founder and CEO of Sylke, Inc.
This summary was developed by Sylke, Inc.
"Silk Bioprotein as a Novel Surgical-Site Wound Dressing"
Prospective RCT · ASJ Open Forum · 2023
Rouhani DS, Singh NK, Chao JJ, Almutairi A, Badowski-Platz R, Seradj MH, Mofid MM. Aesthet Surg J Open Forum. 2023;5:ojad071.
Study Design: Prospective, randomized, single-blinded, split-body superiority trial. Each patient served as their own internal control with silk dressing on one side and Dermabond Prineo on the contralateral side.
Sample Size: N = 25 (abdominoplasty, belt lipectomy, mastopexy, or reduction mammaplasty)
Primary Endpoint: Incidence of medical adhesive-related skin injuries (MARSI) including discomfort, itching, rash, erythema, edema, and need for pharmaceutical intervention.
Key Results: 64% of patients (16/25) reported discomfort of 4/10 or greater on the Dermabond Prineo side vs. 4% (1/25) on the silk side (P < .001). 52% (13/25) had visible rash of 4 or higher on the Dermabond Prineo side vs. 0% (0/25) on the silk side (P < .001).
Adverse Events: No adverse events on the silk dressing side. 52% of patients required corticosteroid or antibiotic treatment for MARSI on the Dermabond Prineo side.
Limitations: Small sample size (N=25); single-center; split-body design limits generalizability to non-bilateral procedures; single-blinded (investigators not blinded); prototype version of the silk dressing was used, not the commercial product.
Author Disclosure: M. Mark Mofid, MD, FACS, has a financial interest in US patent No. 11,311,641 and No. 11,583,607 describing animal bioprotein scaffold wound dressings. N.K. Singh, MD, is a cosmetic medicine section contributing editor for ASJ Open Forum. The remaining authors declared no potential conflicts of interest. The authors received no financial support for the research, authorship, and publication of this article, including payment of the article processing charge. M. Mark Mofid, MD, FACS, is the founder and CEO of Sylke, Inc.
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This summary was developed by Sylke, Inc.
Important U.S. Healthcare Professional Information
Not Medical Advice
This site (including study summaries and any linked resources) is for informational purposes only and is intended for U.S. healthcare professionals. It does not provide medical advice, diagnosis, or treatment. Clinicians must use their independent medical judgment for each patient. If you are a patient, please consult your licensed healthcare professional.
Regulatory Status & On-Label Use
Any product information on this site is limited to the device’s legally marketed, on-label uses in the United States. References to regulatory status are factual only; no FDA approval, clearance, review, or endorsement is implied. Do not use products beyond their intended use and labeling. Always read the current Instructions for Use (IFU) before use: sylke.com/ifu.
Evidence & Clinical Content
Each study listed on this page is accompanied by a structured summary developed by Sylke, Inc. that includes study design, sample size, primary endpoints, key results, adverse events, limitations, and author disclosures. These summaries are provided alongside the full peer-reviewed source publication, which is linked for each study, and are intended to present scientific information in a balanced and non-promotional format consistent with FDA guidance. They do not replace the full publication. The studies described may include comparisons or applications not specifically addressed in the current FDA-required labeling. The safety and effectiveness of any such use(s) have not been established by FDA review. Results from individual studies or centers may not be generalizable to all patient populations or clinical settings. Unless expressly stated, case descriptions and clinician perspectives are illustrative and are not predictive of individual patient outcomes; results vary.
Third-Party Literature & Links
Third-party papers and websites are independent of Sylke. We do not control their content and do not adopt statements that are inconsistent with U.S. labeling. Linked items are provided for scientific context and may be updated or withdrawn by their publishers without notice.
Risk Information
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