Assessment of DAFILON® Suture Material for Skin Closure

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]

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).

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).

Incidence of wound dehiscence (skin) in postoperative course

Incidence of wound dehiscence (skin) in postoperative course

Rates of postoperative complications such as tissue reaction or inflammation, seroma, abscess formation, hematoma, granuloma, bleeding, suture removal or re-suturing in postoperative course

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.

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.

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]

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]

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.

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.

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)

Number of days between date of surgery and date of discharge