Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT04122859
Eligibility Criteria:
Inclusion Criteria:
1. Between 4 to 14 years of age at the time of laceration repair.
2. Require suture closure as standard of care for simple straight wounds on trunk or extremities up to 4 cm long.
3. Low Tension Laceration, e.g. skin can be easily approximated by pinching with fingers.
4. Subject and legal representative(s) are willing and able to comply with the investigational device removal and meet the follow up visit requirements.
5. Subject and legal representative(s) have been informed of the nature, the scope and the relevance of the study.
6. Subject and legal representative(s) have voluntarily agreed to participation and have duly signed the Informed Consent Form.
Exclusion Criteria:
1. Known personal or familial history of scar hypertrophy.
2. Known or suspected allergies or hypersensitivity to non-latex skin adhesives.
3. Atrophic skin deemed clinically prone to blistering.
4. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions ("dirty wounds").
5. Wounds that require deep dermal closure using sutures.
6. Known or suspected mental problems and/or aggressiveness that indicates that the subject might try to remove the device during the treatment period.
7. Participating in any other clinical investigation.
8. Known health condition that would affect healing in the opinion of the investigator.
9. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
14 Years
Study:
NCT04122859
Study Brief:
Protocol Section:
NCT04122859