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

Skin Closure Clinical Trial

— SKINNOQ  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680886
• Other study ID #: AAG-O-H-1505
• Status: Completed
• Start date: March 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Closure

Intervention

Device:
• Novosyn® Quick
Skin closure

Locations

Country	Name	City	State
France	Hospital Saint Louis	La Rochelle
Germany	Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology	Frankfurt am Main

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of wound dehiscence	A dehiscence of the skin which needs surgical treatment with re-closure	3 months postoperatively
Primary	Incidence of Tissue reaction / Inflammation		3 months postoperatively
Primary	Incidence of Suture removal	Suture removal due to insufficient absorption	3 months postoperatively
Primary	Incidence of Re-suturing	Re-Suturing due to dehiscence	3 months post-operatively
Primary	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
Primary	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