Optilene® Suture Material for Dermal Sutures
OPTIDERMAL
Assessment of Optilene® Suture Material for Skin Closure (Dermal Sutures). A Prospective Single-arm Observational Study in Daily Practice
1 other identifier
observational
172
1 country
1
Brief Summary
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedStudy Start
First participant enrolled
June 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2023
CompletedFebruary 21, 2024
February 1, 2024
1 year
January 26, 2022
February 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical Site Infection Rate
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material.
at suture removal approximately 10±5 days postoperatively.
Secondary Outcomes (11)
Surgical Site Infection Rate
at discharge from hospital (up to 5 days postoperatively)
Surgical Site Infection Rate
at follow-up examination approximately 30±10 days postoperatively
Wound dehiscence rate
at discharge from hospital (up to 5 days postoperatively)
Wound dehiscence rate
at suture removal approximately 10±5 days postoperatively.
Wound dehiscence rate
at follow-up examination approximately 30±10 days postoperatively
- +6 more secondary outcomes
Eligibility Criteria
Adult patients undergoing skin closure using Optilene® suture material.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
- B.Braun Surgical SAcollaborator
Study Sites (1)
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2022
First Posted
February 15, 2022
Study Start
June 22, 2022
Primary Completion
June 23, 2023
Study Completion
July 23, 2023
Last Updated
February 21, 2024
Record last verified: 2024-02