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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT04557761
Eligibility Criteria:
Inclusion Criteria:
* Subjects undergoing a laceration repair that would require sutures, staples, or tissue adhesives to close the skin wound.
* Age between 7 and 17 years old
* Written informed consent obtained from Subject or Subject's legal representative
* Ability of Subject to comply with the requirements of the study
Exclusion Criteria:
* Wound in extensor or flexor surface of knee or elbow
* Wound on concave areas of the face, such as orbit of the nasal sidewall
* Wound on fingers or toes
* Wound under high tension
* Wound that has a gap of more than 1 cm between the wound edges immediately prior to application of microMend devices
* Facial or body hair that could impede application of the wound closure device
* Wound with significant tissue injury
* Wound with active bleeding
* Wound where adjacent skin is wet
* Visual evidence of active infection, contaminated or devitalized tissue, or rash at laceration location
* Wound that contain a foreign body
* Wound site that contains tattoo or other identifiable features
* Subject with keloid(s)
* Medical disorder that, in the opinion of the Investigator, could have a significant effect on wound healing
* Pregnancy
* Inability of Subject to carry out Subject instructions
* Subject lacks the capacity to consent
* Currently using medication that, in the opinion of the Investigator, could have a significant effect on wound healing
* Skin disorder, such as psoriasis, or current dermatitis or eczema at wound site
* History of keloids or scar hypertrophy
* Known bleeding diathesis
* Sensitivity or allergy to adhesives or medical tape
* Active infection in any part of the body
* Use of sutures or staples to close underlying skin layers
* Use of staples to close skin wound
* Use of tissue adhesive or other adhesives directly over the wound
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT04557761
Study Brief:
Protocol Section:
NCT04557761