Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ)

Abstract

Background This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures. Methods This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany). Surgeons used a 5-point Likert scale to assess handling characteristics of the suture. Patients and professionals used the Patient-Observer-Scar-Assessment-Scale (POSAS) to rate scar quality. Adverse events were monitored until 3 months postoperatively. Results Handling characteristics of Novosyn® Quick were in median rated very good by both general surgeons and paediatric surgeons. Patient components of POSAS (six questions; ten-level Likert scale; best possible score six) scored in median (range) 8.5 (6–28) in the paediatric group versus 12 (6–38) in the adult group, P = 0.01. Patients` overall opinions of POSAS were similar in both groups [mean (SD), 1.86 (0.99) in the paediatric group versus 2.08 (1.35) in the adult group, P = 0.3536]. Observer component of POSAS (six parameters; ten-level numeric rating scale, best possible score six) scored comparably in both groups [median (range), 8 (6–29) in the paediatric group versus 10 (6–28) in the adult group, P = 0.1403]. Observers overall opinion of POSAS favoured the paediatric patients group [mean (SD), 1.48 (0.61) versus 1.92 (1.06) in the adult group, P = 0.0131]. Adverse events in relation to wound healing were not observed in both patient groups. Conclusions Our findings indicate, that Novosyn ® Quick is safe and reliable for skin closure in adults and paediatric patients and can be regarded as a viable alternative to Vicryl ® Rapide. Trial registration This trial was registered prospectively with ClinicalTrials.gov under the registration number NCT02680886 on 5 February 2016. The trial was approved by the Institutional Review Boards of both study locations (France: CCTIRS N° 16–103 and CNIL:MMS/CWR/AR163920; Germany: 398/15). Electronic supplementary material The online version of this article (10.1186/s12893-019-0506-8) contains supplementary material, which is available to authorized users.

Prospective, Observational Study to Assess a New Quick Absorbable Monofilament Suture for Skin Closure in Adults

“…The ideal suture material to close the skin is characterized by an easy handling and sufficient tensile strength to support the healing phase [1]. In addition, its application should cause a minimal tissue reaction and should lead to an excellent cosmetic outcome [1]. Non-absorbable as well as absorbable sutures are in common use for skin approximation [1].…”

“…In addition, its application should cause a minimal tissue reaction and should lead to an excellent cosmetic outcome [1]. Non-absorbable as well as absorbable sutures are in common use for skin approximation [1]. A disadvantage of non-absorbable sutures is that they must be removed approximately 7-14 days after surgery, which is time-consuming and unpleasant for the patient [1].…”

“…Non-absorbable as well as absorbable sutures are in common use for skin approximation [1]. A disadvantage of non-absorbable sutures is that they must be removed approximately 7-14 days after surgery, which is time-consuming and unpleasant for the patient [1]. In contrast, absorbable suture are degraded by hydrolysis in the body after a certain period and suture removal can be avoided.…”