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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novosyn® Quick | Skin closure using rapid absorbable suture material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novosyn® Quick | Device | Skin closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection | Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC). | 3 months |
| Incidence of wound dehiscence | A dehiscence of the skin which needs surgical treatment with re-closure | 3 months postoperatively |
| Incidence of Tissue reaction / Inflammation | 3 months postoperatively | |
| Incidence of Suture removal | Suture removal due to insufficient absorption | 3 months postoperatively |
| Incidence of Re-suturing | Re-Suturing due to dehiscence | 3 months post-operatively |
| Cosmetic result | Cosmetic result after surgery using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome using the patient component of the Patient and Observer Scar Assessment Scale (POSAS). The physician will use the Observer component of the POSAS to assess the cosmetic outcome. Documentation of the scar will be performed 3 months postoperatively using photographs. Overall patient and observer satisfaction with the scar after 3 months postoperatively (POSAS). | 3 months post-operatively |
| Assessment of the handling of the suture material | Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor). |
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Inclusion Criteria:
Exclusion Criteria:
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children and adults
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Saint Louis | La Rochelle | 17019 | France | |||
| Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31046730 | Derived | Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn(R) Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8. |
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| intraoperatively |
| Frankfurt am Main |
| 60590 |
| Germany |