LacerationOPTIDERMALNCT05240248
Optilene® Suture Material for Dermal Sutures
An observational study of Laceration and Incision, run by Aesculap AG at 1 site in Spain.
Trial summary
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laceration, Incision
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2022to 23 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing skin closure using Optilene® suture material.
Who may be able to join
- 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.
Who cannot join
- Emergency surgery.
- Transplant surgery.
- Pregnancy.
- Facial laceration or incision.
- Visible dirt in the wound.
- Non-linear shape.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Optilene® Suture Material for Skin Closure (Dermal Sutures). A Prospective Single-arm Observational Study in Daily Practice
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
Read the 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 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
- Laceration, Incision
- Medical subject headings
- Lacerations, Surgical Wound
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at suture removal approximately 10±5 days postoperatively.
Secondary outcomes (11)
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.
Measured: at discharge from hospital (up to 5 days postoperatively)
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.
Measured: at follow-up examination approximately 30±10 days postoperatively
Wound dehiscence rate
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Measured: at discharge from hospital (up to 5 days postoperatively)
Wound dehiscence rate
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Measured: at suture removal approximately 10±5 days postoperatively.
Wound dehiscence rate
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Measured: at follow-up examination approximately 30±10 days postoperatively
Cumulative rate of Adverse Events during the study period
frequency of Tissue reaction, Inflammation, Seroma, Abscess formation, Hematoma, Granuloma, Bleeding, Necrosis and Irritation
Measured: at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Development of Cosmetic Outcome
Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum).
Measured: at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Development of Pain: Visual Analogue Scale (VAS)
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".
Measured: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Development of Satisfaction of the patient: Visual Analogue Scale (VAS)
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "very poor" and "100" at the opposite end representing "excellent".
Measured: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Duration of surgery
time from cut to closure in minutes.
Measured: intraoperatively
Handling of the suture material
The handling of the suture material is assessed using a questionnaire assessing the Knot security (The quality of a suture that allows it to be tied securely with a minimum number of throws per knot), the Knot pull tensile strength (strength of the thread while knotting), the Knot run down (Ease with which a knot can be slid down), the Tissue drag (Passage through the tissue), the Pliability (The quality of being easily to bent, flexibility) and the Overall opinion of the surgeon each with the 5 evaluation levels of 'excellent', 'very good', 'good', 'satisfied' and 'poor':.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start22 Jun 2022
- Primary completion23 Jun 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240248
- Sponsor's protocol ID
- AAG-O-H-1928
- Acronym
- OPTIDERMAL
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Optilene® Suture Material for Skin Closure (Dermal Sutures). A Prospective Single-arm Observational Study in Daily Practice
- ClinicalTrials.gov ID
- NCT05240248
- Acronym / sponsor ID
- OPTIDERMAL / AAG-O-H-1928
- Conditions
- Laceration, Incision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing skin closure using Optilene® suture material.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Emergency surgery.
- Transplant surgery.
- Pregnancy.
- Facial laceration or incision.
- Visible dirt in the wound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical Site Infection Rate
Time frame: at suture removal approximately 10±5 days postoperatively.
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.
11 secondary outcomes
Surgical Site Infection Rate
Time frame: at discharge from hospital (up to 5 days postoperatively)
Surgical Site Infection Rate
Time frame: at follow-up examination approximately 30±10 days postoperatively
Wound dehiscence rate
Time frame: at discharge from hospital (up to 5 days postoperatively)
Wound dehiscence rate
Time frame: at suture removal approximately 10±5 days postoperatively.
Wound dehiscence rate
Time frame: at follow-up examination approximately 30±10 days postoperatively
Cumulative rate of Adverse Events during the study period
Time frame: at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Development of Cosmetic Outcome
Time frame: at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Development of Pain: Visual Analogue Scale (VAS)
Time frame: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Development of Satisfaction of the patient: Visual Analogue Scale (VAS)
Time frame: at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively
Duration of surgery
Time frame: intraoperatively
Handling of the suture material
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laceration and Incision, run by Aesculap AG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection Rate (time frame: at suture removal approximately 10±5 days postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.