Plastic and reconstructive surgery · 2024
Superiority of a Silk Surgical Site Wound Closure Device over Synthetic Dressings.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Rouhani Daniel S, Singh Navin K, Chao James J, Almutairi Adah, Seradj Mehran H, Badowski-Platz Rebecca, Toranto Jason D, Mofid M Mark
Аннотация
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 randomized, single-blind clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on 1 side of their body and 3M Steri-Strips on the contralateral side after abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data were collected over 5 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 the results with a previously published study comparing Dermabond Prineo with the silk dressing.
RESULTS: A total of 20.8% of patients (10 of 48) were assessed by surgeons as having skin erythema (7 to 10) on the Steri-Strip control side, with 0% (0 of 48) on the silk dressing side ( P = 0.002). The frequency of breast triple-point separation in 43 cases was 30.2% (13 of 43) on the Steri-Strip side and 9.3% (4 of 43) on the silk side ( P = 0.012). A total of 75% of patients (36 of 48) had partial or total detachment of Steri-Strips, 0% (0 of 48) had total detachment of the silk dressing, and 18.8% (9 of 48) had partial detachment of the silk dressing within the first 2 weeks ( P < 0.001).
CONCLUSION: A silk fibroin wound dressing significantly reduces the incidence of wound-healing complications throughout the postoperative period.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
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.
METHODS: A randomized, single-blind clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on 1 side of their body and 3M Steri-Strips on the contralateral side after abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data were collected over 5 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 the results with a previously published study comparing Dermabond Prineo with the silk dressing.
RESULTS: A total of 20.8% of patients (10 of 48) were assessed by surgeons as having skin erythema (7 to 10) on the Steri-Strip control side, with 0% (0 of 48) on the silk dressing side ( P = 0.002). The frequency of breast triple-point separation in 43 cases was 30.2% (13 of 43) on the Steri-Strip side and 9.3% (4 of 43) on the silk side ( P = 0.012). A total of 75% of patients (36 of 48) had partial or total detachment of Steri-Strips, 0% (0 of 48) had total detachment of the silk dressing, and 18.8% (9 of 48) had partial detachment of the silk dressing within the first 2 weeks ( P < 0.001).
CONCLUSION: A silk fibroin wound dressing significantly reduces the incidence of wound-healing complications throughout the postoperative period.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
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.