Clinical Evidence
Prospective, Randomized, Single-Blinded, Clinical Trial
Silk Bioprotein as a Novel Surgical-Site Wound Dressing
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 to 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 undergoing abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data was collected over 5 postoperative visits using photographs and an investigator-administered questionnaire to monitor erythema, skin irritation, skin discomfort, the need for pharmaceutical intervention, wound dehiscence, and mechanical skin injury. A comprehensive 75-patient statistical analysis was conducted, combining the results with a previously published study comparing Dermabond® Prineo® to the silk dressing.
Results: 20.8% (10/48) of patients were assessed by surgeons as having skin erythema (7-10) on the Steri-Strip® control side, and 0% (0/48) on the silk dressing side (p=0.002). The frequency of breast triple point separation in 43 cases was 30.2% (13/43) on the Steri-Strip® side and 9.3% (4/43) on the silk side (p=0.012). 75% (36/48) of patients had partial or total detachment of Steri-Strips®, while 0% (0/48) had total detachment of the silk dressing and 18.8% (9/48) had partial detachment of the silk dressing 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.
Clinical Relevance Statement: The adoption of a silk fibroin wound dressing into clinical practice has the potential to improve patient outcomes, decrease medical adhesive-related skin injuries, and reduce the rate of wound healing complications.
Prospective, Randomized, Single-Blinded, Clinical Trial
Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings
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 to 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 undergoing abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data was collected over 5 postoperative visits using photographs and an investigator-administered questionnaire to monitor erythema, skin irritation, skin discomfort, the need for pharmaceutical intervention, wound dehiscence, and mechanical skin injury. A comprehensive 75-patient statistical analysis was conducted, combining the results with a previously published study comparing Dermabond® Prineo® to the silk dressing.
Results: 20.8% (10/48) of patients were assessed by surgeons as having skin erythema (7-10) on the Steri-Strip® control side and 0% (0/48) on the silk dressing side (p=0.002). The frequency of breast triple point separation in 43 cases was 30.2% (13/43) on the Steri-Strip® side and 9.3% (4/43) on the silk side (p=0.012). 75% (36/48) of patients had partial or total detachment of Steri-Strips®, while 0% (0/48) had total detachment of the silk dressing and 18.8% (9/48) had partial detachment of the silk dressing 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.
Clinical Relevance Statement: The adoption of a silk fibroin wound dressing into clinical practice has the potential to improve patient outcomes, decrease medical adhesive-related skin injuries, and reduce the rate of wound healing complications.
Interested in Research?
Advancing Wound Closure Technology Together
At SYLKE®, we’re passionate about pushing the boundaries of wound healing through innovation and research. We welcome partnerships with healthcare professionals and institutions eager to explore new possibilities in surgical wound closure. Let’s work together to improve patient outcomes and revolutionize postoperative care.