SKINNOQ: PMCF-study Using Novosyn® Quick Suture Material for Skin Closure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Novosyn® Quick Skin closure using rapid absorbable suture material |
Device: Novosyn® Quick
Skin closure
|
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Saint Louis | La Rochelle | France | 17019 | |
| 2 | Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology | Frankfurt am Main | Germany | 60590 |
Sponsors and Collaborators
- Aesculap AG
- B.Braun Surgical SA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-O-H-1505