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

May 3, 2018 updated by: Aesculap AG

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Rochelle, France, 17019
        • Hospital Saint Louis
  • Germany
      • Frankfurt am Main, Germany, 60590
        • Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children and adults

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Novosyn® Quick
Skin closure using rapid absorbable suture material
Device: Novosyn® Quick
Skin closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection
Time Frame: 3 months
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
Time Frame: 3 months postoperatively
A dehiscence of the skin which needs surgical treatment with re-closure
3 months postoperatively
Incidence of Tissue reaction / Inflammation
Time Frame: 3 months postoperatively
3 months postoperatively
Incidence of Suture removal
Time Frame: 3 months postoperatively
Suture removal due to insufficient absorption
3 months postoperatively
Incidence of Re-suturing
Time Frame: 3 months post-operatively
Re-Suturing due to dehiscence
3 months post-operatively
Cosmetic result
Time Frame: 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).
3 months post-operatively
Assessment of the handling of the suture material
Time Frame: 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).
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (ESTIMATE)

February 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-O-H-1505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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