Assessment of DAFILON® Suture Material for Skin Closure

Study Overview
=================
Brief Summary
-----------------
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients. The aim of the study is to collect clinical data on the performance of Dafilon® for skin closure. The results of this study will generate further clinical evidence for the use and the benefit of a non-absorbable surgical suture material produced from polyamide. Furthermore, the proactive collection of clinical data for Dafilon® suture will support the maintenance of the suture material on the market, so that in the future other patients can receive the suture material for skin closure.

Official Title
-----------------
Assessment of DAFILON® Suture Material for Skin Closure: A Prospective, Multicentric, International, Single-arm, Observational Study in Daily Practice

Conditions
-----------------
Laceration of Skin, Injury Skin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Written informed consent is available Patients undergoing skin closure with Dafilon® Small linear minimally contaminated incision/laceration in the trunk or extremities Exclusion: Emergency surgery Pregnancy Facial lacerations or incisions Visible dirt in the wounds Nonlinear shape Patient taking medication that might affect wound healing Patient with hypersensitivity or allergy to the suture material
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination of Surgical Site Infection (SSI) and Wound Dehiscence | The hypotheses of the current study is that the combined endpoint which consists of the sum of the wound dehiscence and SSI rate will not be inferior to the rate of 13% published by Sajid M. S. et al., 2014 [Systematic review of absorbable vs non-absorbable sutures used for the closure of surgical incisions. World J Gastrointest Surg 2014 27;6(12): 241-247] | until suture removal 10±5 days postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual rate of surgical site infection (SSI) at discharge | Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC). | until day of discharge (approximately 1-2 days postoperatively) | 
| Individual rate of surgical site infection (SSI) at postoperative Examination | Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC). | 10±5 days postoperatively | 
| Individual dehiscence rate at discharge | Incidence of wound dehiscence (skin) in postoperative course | until day of discharge (approximately 1-2 days postoperatively) | 
| Individual dehiscence rate at postoperative Examination | Incidence of wound dehiscence (skin) in postoperative course | 10±5 days postoperatively | 
| Adverse events | Rates of postoperative complications such as tissue reaction or inflammation, seroma, abscess formation, hematoma, granuloma, bleeding, suture removal or re-suturing in postoperative course | until 10±5 days postoperatively | 
| Progress of Wound healing | This parameter will be noted using the Visual Analogue Scale (VAS) which states 0 at one end representing worst wound healing and 10 at the opposite end representing excellent wound healing. The values are compared over postoperative period. | until day of discharge (approximately 1-2 days postoperatively), 10±5 days post operatively and at follow-up visit | 
| Progress of Cosmetic result | Overall patient and observer satisfaction with the scar 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 in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum). The values are compared over postoperative period. | at 10±5 days (suture removal) and at optional follow-up visit | 
| Rate of hypertrophic scar | A hypertrophic scar is a cutaneous condition characterized by deposits of excessive amounts of collagen which gives rise to a raised scar, but not to the degree observed with keloids. [wikipedia] | 10±5 days postoperatively (suture removal) | 
| Rate of keloid scar | Keloidal scar is the formation of a type of scar which, depending on its maturity, is composed mainly of either type III (early) or type I (late) collagen. It is a result of an overgrowth of granulation tissue (collagen type 3) at the site of a healed skin injury which is then slowly replaced by collagen type 1. Keloids should not be confused with hypertrophic scars, which are raised scars that do not grow beyond the boundaries of the original wound. [wikipedia] | 10±5 days postoperatively (suture removal) | 
| Progress of Pain: Visual Analogue Scale (VAS) | This parameter will be noted using the Visual Analogue Scale (VAS) which state 0 at one end representing no pain and 100 at the opposite end representing heavy pain. The values are compared over postoperative period. | until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively | 
| Progress of Satisfaction: Visual Analogue Scale (VAS) | This parameter will be noted using the Visual Analogue Scale (VAS) which state 0 at one end representing very poor and 100 at the opposite end representing excellent. The values are compared over postoperative period. | until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively | 
| 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, stiffness, etc.) with 5 evaluation levels (excellent, very good, good, satisfied, poor) | intra-operatively | 
| Length of hospital stay | Number of days between date of surgery and date of discharge | until day of discharge (approximately 1-2 days postoperatively) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-absorbable suture, Skin closure, Surgical site infection, Wound dehiscence