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 centr...
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| Format: | Article |
| Language: | English |
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BMC
2019-05-01
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| Series: | BMC Surgery |
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| Online Access: | http://link.springer.com/article/10.1186/s12893-019-0506-8 |
| _version_ | 1818215360589987840 |
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| author | Stefan Gfroerer Petra Baumann Anne-Kathrin Schwalbach Alexandre Smirnoff |
| author_facet | Stefan Gfroerer Petra Baumann Anne-Kathrin Schwalbach Alexandre Smirnoff |
| author_sort | Stefan Gfroerer |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-12-12T06:34:51Z |
| format | Article |
| id | doaj.art-f9ea321c4be144b2a90804227a71fdd3 |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-12-12T06:34:51Z |
| publishDate | 2019-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Surgery |
| spelling | doaj.art-f9ea321c4be144b2a90804227a71fdd32022-12-22T00:34:30ZengBMCBMC Surgery1471-24822019-05-011911910.1186/s12893-019-0506-8Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ)Stefan Gfroerer0Petra Baumann1Anne-Kathrin Schwalbach2Alexandre Smirnoff3Department of Paediatric Surgery and Paediatric Urology, University Hospital FrankfurtAesculap AG, Medical Scientific AffairsDepartment of Paediatric Surgery and Paediatric Urology, University Hospital FrankfurtService de chirurgie viscérale, Hôpital Saint-LouisAbstract 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).http://link.springer.com/article/10.1186/s12893-019-0506-8Skin closureFast-absorbable braided suturePaediatric |
| spellingShingle | Stefan Gfroerer Petra Baumann Anne-Kathrin Schwalbach Alexandre Smirnoff Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ) BMC Surgery Skin closure Fast-absorbable braided suture Paediatric |
| title | Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ) |
| title_full | Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ) |
| title_fullStr | Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ) |
| title_full_unstemmed | Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ) |
| title_short | Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ) |
| title_sort | prospective international multicenter observational study of novosyn r quick for skin closures in adults and children skinnoq |
| topic | Skin closure Fast-absorbable braided suture Paediatric |
| url | http://link.springer.com/article/10.1186/s12893-019-0506-8 |
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