Last updated: March 11, 2022
Sponsor: Children's Hospital of Orange County
Overall Status: Active - Recruiting
Phase
N/A
Condition
Skin Wounds
Treatment
N/AClinical Study ID
NCT04557761
1912154
Ages 7-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects undergoing a laceration repair that would require sutures, staples, or tissueadhesives 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
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 toapplication 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 atlaceration 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 significanteffect 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 asignificant 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
Study Design
Total Participants: 30
Study Start date:
July 13, 2020
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
CHOC Children's
Orange, California 92868
United StatesActive - Recruiting
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