Comparison of microMend® Devices to Sutures in Closing Lacerations in Children (NCT04557761) | Clinical Trial Compass
UnknownNot Applicable
Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
United States30 participantsStarted 2020-07-13
Plain-language summary
This study will gather information on the use of microMend® to repair lacerations in children and compare the efficacy of microMend® to sutures for laceration repair. microMend® has previously been shown to be less painful and easier to use than sutures, which are the current standard of care for primary wound closures. Results of this research will inform how the treatment of laceration repairs in the pediatric patient population.
Who can participate
Age range7 Years – 17 Years
SexALL
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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 …
What they're measuring
1
Investigator's Assessment of Wound Closure Device (Questionnaire)
Timeframe: During wound-closure performance
2
Investigator's Assessment of Wound Closure Device (Survey)