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

Completed

• Conditions: Skin Closure
• Interventions: Device: Novosyn® Quick

• Registration Number: NCT02680886
• Lead Sponsor: Aesculap AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Study Start: 2016-03
• Primary Completion: 2017-10
• Status Verified: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novosyn® Quick	Novosyn® Quick	Skin closure using rapid absorbable suture material

Primary Outcome Measures

Name	Time	Method
Wound infection	3 months	Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).
Incidence of wound dehiscence	3 months postoperatively	A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Tissue reaction / Inflammation	3 months postoperatively
Incidence of Suture removal	3 months postoperatively	Suture removal due to insufficient absorption
Incidence of Re-suturing	3 months post-operatively	Re-Suturing due to dehiscence
Cosmetic result	3 months post-operatively	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).
Assessment of the handling of the suture material	intraoperatively	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).

Trial Locations

Locations (2)

Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology; 🇩🇪 Frankfurt am Main, Germany

Hospital Saint Louis; 🇫🇷 La Rochelle, France