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Completed

NCT Number: NCT02680886

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

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.

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Key information

Conditions

Skin Closure

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Saint Louis, La Rochelle, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novosyn® Quick

Device

Skin closure

Primary outcomes

  1. 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).

  2. Incidence of wound dehiscence

    Time frame: 3 months postoperatively

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

  3. Incidence of Tissue reaction / Inflammation

    Time frame: 3 months postoperatively

  4. Incidence of Suture removal

    Time frame: 3 months postoperatively

    Suture removal due to insufficient absorption

  5. Incidence of Re-suturing

    Time frame: 3 months post-operatively

    Re-Suturing due to dehiscence

  6. 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).

  7. 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).

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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

Acronym: SKINNOQ

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 12, 2016
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.