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

Aesculap AG100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Skin Closure

Interventions

Novosyn® QuickDEVICE

Skin closure

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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

Locations (2)

Hospital Saint Louis

La Rochelle, France

Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology

Frankfurt am Main, Germany

Outcomes

Primary Outcomes

Wound infection

Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).

Time frame: 3 months

Incidence of wound dehiscence

A dehiscence of the skin which needs surgical treatment with re-closure

Time frame: 3 months postoperatively

Incidence of Tissue reaction / Inflammation

Time frame: 3 months postoperatively

Incidence of Suture removal

Suture removal due to insufficient absorption

Time frame: 3 months postoperatively

Incidence of Re-suturing

Re-Suturing due to dehiscence

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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