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.
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.