NCT02680886

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 4, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

February 5, 2016

Last Update Submit

May 3, 2018

Conditions

Skin Closure

Keywords

Rapid Absorbable Suture MaterialChildren / AdultsNovosyn Quick

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

Novosyn® Quick

Skin closure using rapid absorbable suture material

Device: Novosyn® Quick

Interventions

Novosyn® QuickDEVICE

Skin closure

Novosyn® Quick

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

children and adults

You may qualify if:

  • Pediatric and adult patients undergoing skin closure
  • Small linear minimally contaminated incision / lacerations on the trunk or extremities
  • Written informed consent

You may not qualify if:

  • Emergency surgery
  • Facial lacerations or incisions
  • Visible dirt in the wounds
  • Nonlinear shape
  • Patients taking medical consumption that might affect wound healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Saint Louis

La Rochelle, 17019, France

Location

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

Frankfurt am Main, 60590, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31046730DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 12, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

May 4, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)FR(1)