Assessment of DAFILON® Suture Material for Skin Closure (SKINDA)

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

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.

Study Overview

• Status: Completed
• Conditions: Laceration of Skin; Injury Skin

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tuttlingen, Baden-Württemberg, Germany, 78532
      • Klinikum Landkreis Tuttlingen, Dept. General Surgery
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patients and children

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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)

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Manuel Guillermo López Paredes, Dr., Hospital Vall D'Hebrón, Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Surgical site infection; Skin closure; Wound dehiscence; Non-absorbable suture
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: AAG-O-H-1909