Optilene® Suture Material for Dermal Sutures

NCT ID: NCT05240248

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-22

Study Completion Date

2023-07-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Laceration Incision

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 same patient, only one incision will be included).
* Written informed consent.

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. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants).
* Patient with hypersensitivity or allergy to the suture material.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AAG-O-H-1928

Identifier Type: -

Identifier Source: org_study_id

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