Clinical Evidence

Retrospective Cohort Study

Silk Fibroin Wound Dressing Significantly Decreases Hypersensitivity Compared to 2-Octyl Cyanoacrylate Mesh Dressing

Authors: Klara I.M. Aastroem, BS; Nana O. Sarpong, MD MBA; Alexander L. Neuwirth, MD; H. John Cooper, MD; Jeffrey A. Geller, MD; Roshan P. Shah, MD JD

June 24, 2025

Background: Mesh dressings sealed with 2-octyl cyanoacrylate have been associated with hypersensitivity following total joint arthroplasty (TJA). Silk fibroin is a biopolymer available as a novel adhesive woven dressing that does not require skin glue and allows permeability. The purpose of this study was to compare hypersensitivity, delayed wound healing, wound edge separation, reoperations within 90 days, dressing application time, and cost differences between silk dressings and 2-octyl cyanoacrylate mesh dressings.

Methods: We reviewed 261 consecutive patients who received either silk or mesh dressings for the incidence of hypersensitivity, delayed wound healing, wound edge separation, reoperations, dressing application time, and cost after TJA. Silk fibroin dressings were used in 58 patients, while 2-octyl cyanoacrylate mesh dressings were used in 203 patients. Statistical analyses were performed using independent t-tests, χ² tests, two-sided Fisher’s exact tests, and multivariate logistic regressions.

Results: The silk group had a lower rate of hypersensitivity (0 vs 9.9%, P = 0.009). We observed delayed wound healing associated with hypersensitivity in 1% of mesh patients. There were no cases of wound edge separation in knee cases in either group. There were no differences in reoperations. With silk dressings, the total average cost savings were \$465.91 per case, comprising \$327.34 in dressing cost savings and \$138.57 in operating-room cost savings, with an average of 3.7 minutes of operating-room time saved.

Conclusions: Silk fibroin dressing was associated with less hypersensitivity and shorter application time compared to 2-octyl cyanoacrylate mesh dressings, with no cases of wound edge separation upon removing the silk dressing, even with early knee-motion protocols. Although direct costs vary with institutional pricing, substantial savings were observed with the silk dressing, and eliminating glue-drying time saved an average of 3.7 minutes, which can be impactful in health systems lacking parallel-processing efficiencies.
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Retrospective Cohort Study

Silk Fibroin Closure Eliminates the Incidence of Allergic Contact Dermatitis Compared to Cyanoacrylate Mesh in Total Joint Arthroplasty

Authors: Justin P. Moo Young, MD; Viraj A. Deshpande, BS; Susanne Porter, FNP-BC; Edward J. Quilligan, BS; Travis Scudday, MD; Steven Barnett, MD; Robert Gorab, MD

March 24, 2025

Background: Allergic contact dermatitis (ACD) from adhesive wound-closure systems can increase postoperative complications after total joint arthroplasty (TJA). This high-volume orthopaedic-hospital study compared wound complications between a cyanoacrylate mesh (CM) adhesive and a silk fibroin (SF) adhesive.

Methods: All TJAs from January 2019 to April 2024 with ≥6 weeks of postoperative follow-up were retrospectively reviewed. Demographics and surgical outcomes were analyzed with Fisher’s exact tests and t-tests.

Results: Power analysis required 170 CM and 85 SF subjects. Among 257 patients (172 CM, 85 SF; mean age 65.3 ± 9.0 years; BMI 28.0 ± 4.6), groups were similar in demographics/comorbidities except ASA 1 frequency (3.9% vs 1.7%; P =.011). CM showed higher ACD incidence (6.4% vs 0%; P =.018); other clinical outcomes were not significantly different.

Conclusions: SF adhesive produced a very low overall complication rate and eliminated ACD observed with CM adhesive, supporting SF as a superior closure option for TJA.
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Prospective, Randomized, Single-Blinded, Clinical Trial

Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings

Authors: Daniel S. Rouhani, BS; Navin K. Singh, MD MBA MSc; James J. Chao, MD PhD MBA; Adah Almutairi, PhD; Mehran H. Seradj, MD; Rebecca Badowski-Platz, BS; Jason D. Toranto, MD; M. Mark Mofid, MD

February 7, 2024

Background: Silk fibroin is an emerging biomaterial with enhanced properties of cellular regeneration, growth, and proliferation. The use of a silk fibroin wound dressing has the potential to decrease the incidence of wound-healing complications and to improve patient outcomes compared with synthetic dressing alternatives.

Methods: A prospective, randomized, single-blinded clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on one side of their body and, on the contralateral side, with 3M Steri-Strips® after abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data were collected over five postoperative visits using photographs and an investigator-administered questionnaire to monitor erythema, skin irritation, skin discomfort, need for pharmaceutical intervention, wound dehiscence, and mechanical skin injury. A comprehensive 75-patient statistical analysis was conducted, combining these results with a previously published study comparing Dermabond® Prineo® to the silk dressing.

Results: Twenty-point-eight percent (10 / 48) of patients were assessed by surgeons as having skin erythema (scores 7–10) on the Steri-Strip control side versus 0 percent (0 / 48) on the silk dressing side (p = 0.002). Breast triple-point separation in 43 cases occurred in 30.2 percent (13 / 43) with Steri-Strips and 9.3 percent (4 / 43) with the silk dressing (p = 0.012). Partial or total detachment of Steri-Strips occurred in 75 percent (36 / 48) of patients, whereas total detachment of the silk dressing was 0 percent and partial detachment 18.8 percent (9 / 48) within the first two weeks (p < 0.001).

Conclusion: A woven silk fibroin wound dressing significantly reduces the incidence of wound-healing complications throughout the postoperative period and outperforms synthetic dressings in maintaining adherence and minimizing skin irritation.
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Prospective, Randomized, Single-Blinded, Clinical Trial

Silk Bioprotein as a Novel Surgical-Site Wound Dressing

Authors: Daniel S. Rouhani, BS; Navin K. Singh, MD MBA MSc; James J. Chao, MD PhD MBA; Adah Almutairi, PhD; Rebecca Badowski-Platz, BS; Mehran H. Seradj, MD; Mehrdad Mark Mofid, MD

October 20, 2023

Background: Silk fibroin is an emerging biomaterial with enhanced properties of cellular regeneration, growth, and proliferation. The use of a silk fibroin wound dressing has the potential to decrease the incidence of wound-healing complications and to improve patient outcomes compared with synthetic dressing alternatives.

Methods: A prospective, randomized, single-blinded clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on one side of their body and, on the contralateral side, with 3M Steri-Strips® after abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data were collected over five postoperative visits using photographs and an investigator-administered questionnaire to monitor erythema, skin irritation, skin discomfort, need for pharmaceutical intervention, wound dehiscence, and mechanical skin injury. A comprehensive 75-patient statistical analysis combined these results with a previously published study comparing Dermabond® Prineo® to the silk dressing.

Results: Twenty-point-eight percent (10/48) of patients had surgeon-assessed skin erythema (scores 7-10) on the Steri-Strip control side versus 0 percent (0/48) on the silk dressing side (p = 0.002). Breast triple-point separation occurred in 30.2 percent (13/43) with Steri-Strips and 9.3 percent (4/43) with the silk dressing (p = 0.012). Partial or total detachment of Steri-Strips occurred in 75 percent (36/48) of patients, whereas total detachment of the silk dressing was 0 percent and partial detachment 18.8 percent (9/48) within the first two weeks (p < 0.001).

Conclusion: A silk fibroin wound dressing significantly reduces the incidence of wound-healing complications throughout the postoperative period.
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