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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02680886

Acronym

SKINNOQ

Enrollment

100

Registered

2016-02-12

Start date

2016-03-31

Completion date

2018-01-31

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Closure

Keywords

Rapid Absorbable Suture Material, Children / Adults, Novosyn Quick

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.

Interventions

DEVICENovosyn® Quick

Skin closure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026