Optilene® Suture Material for Dermal Sutures

Last updated: February 20, 2024
Sponsor: Aesculap AG
Overall Status: Completed

Phase

N/A

Condition

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT05240248
AAG-O-H-1928
  • Ages > 18
  • All Genders

Study Summary

In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients undergoing skin closure using Optilene® suture material.
  • Small (0.5 cm - 10 cm) linear minimally contaminated incision/laceration in the trunk,neck or extremities (in the event that more than one incision is performed in the samepatient, only one incision will be included).
  • Written informed consent.

Exclusion

Exclusion Criteria:

  • Emergency surgery.
  • Transplant surgery.
  • Pregnancy.
  • Facial laceration or incision.
  • Visible dirt in the wound.
  • Non-linear shape.
  • Patient with limb ischemia.
  • Patient taking medication that might affect wound healing (i.e. cytotoxicantineoplastic and immunosuppressive agents, corticosteroids, nonsteroidalanti-inflammatory drugs (NSAIDs), anticoagulants).
  • Patient with hypersensitivity or allergy to the suture material.

Study Design

Total Participants: 172
Study Start date:
June 22, 2022
Estimated Completion Date:
July 23, 2023

Study Description

The study is designed as a prospective, unicentric and single-arm observational study to evaluate Optilene® suture material for skin closure.

The product under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). After operation the investigator will examine the patients at discharge, at 10±5 days after surgery (removal of the suture) and 30±10 days postoperatively.

Connect with a study center

  • Hospital Universitario Doctor Peset

    Valencia, 46017
    Spain

    Site Not Available

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