PMCF-study Using Novosyn® Quick Suture Material for Skin Closure

Study Overview
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Brief Summary
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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.

Official Title
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Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study

Conditions
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Skin Closure

Intervention / Treatment
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* Device: Novosyn® Quick


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric and adult patients undergoing skin closure Small linear minimally contaminated incision / lacerations on the trunk or extremities Written informed consent Exclusion Criteria: Emergency surgery Facial lacerations or incisions Visible dirt in the wounds Nonlinear shape Patients taking medical consumption that might affect wound healing

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novosyn® Quick<br>Skin closure using rapid absorbable suture material | Device: Novosyn® Quick<br>* Skin closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid Absorbable Suture Material, Children / Adults, Novosyn Quick