Status:
COMPLETED
Optilene® Suture Material for Dermal Sutures
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Laceration
Incision
Eligibility:
All Genders
18+ years
Brief Summary
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 23 2023
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05240248
Start Date
June 22 2022
End Date
July 23 2023
Last Update
February 21 2024
Active Locations (1)
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1
Hospital Universitario Doctor Peset
Valencia, Spain, 46017