Assessment of DAFILON® Suture Material for Skin Closure

NCT04617041 | Completed

• 1 other identifier: AAG-O-H-1909
• Study Type: observational
• Target: 115
• Locations: 2 countries
• Sites: 2

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.

Conditions

Laceration of Skin; Injury Skin

Keywords

Non-absorbable suture; Skin closure; Surgical site infection; Wound dehiscence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Individual rate of surgical site infection (SSI) at discharge

  until day of discharge (approximately 1-2 days postoperatively)

• Individual rate of surgical site infection (SSI) at postoperative Examination

  10±5 days postoperatively

• Individual dehiscence rate at discharge

  until day of discharge (approximately 1-2 days postoperatively)

• Individual dehiscence rate at postoperative Examination

  10±5 days postoperatively

• Adverse events

  until 10±5 days postoperatively

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients and children

You may qualify if:

• Written informed consent is available
• Patients undergoing skin closure with Dafilon®
• Small linear minimally contaminated incision/laceration in the trunk or extremities

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (2)

Klinikum Landkreis Tuttlingen, Dept. General Surgery

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Guillermo López Paredes, Dr.

  Hospital Vall D'Hebrón, Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 5, 2020
• Study Start: March 11, 2021
• Primary Completion: May 25, 2023
• Study Completion: June 15, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

ES (1); DE (1)