Recruiting

microMend Device

Sponsor:

KitoTech Medical, Inc.

Code:

NCT03830515

Conditions

Lacerations

Wounds

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

microMend

Study Details

Brief summary:

In this study, total of 20 subjects will have lacerations will be closed with microMend, which is an FDA-listed wound closure product. microMend is a wound closure device that is the size and shape of a butterfly bandage and incorporates tiny Microstaples into an adhesive backing. Assessments by practitioners and Subjects of microMend will be made at Days 0 10, and 3 months using a combination of questionnaires and photographs.

Conditions

Lacerations

Wounds

Study ID

NCT03830515

Start date

Apr 20, 2018

Status verified date

Feb, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Oct 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Subjects undergoing a laceration repair that would require sutures, staples, or tissue adhesives to close the skin wound
  • Age equal to or greater than 18 years old
  • Written informed consent obtained from Subject or Subject's legal representative and ability for Subject to comply with the requirements of the Study

Exclusion Criteria

  • Wound on face
  • Wound on flexor surfaces such as over joints
  • Wound on digits (fingers or toes)
  • Wound under high tension, which is not closed with subcutaneous sutures before application of microMend devices
  • Wound that has a gap of more than 1 cm between the wound edges immediately prior to application of microMend devices
  • Wound with jagged or irregular edges
  • Wound with significant tissue injury
  • 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 Provider, could have a significant effect on wound healing
  • Pregnancy
  • Inability of Subject to carry out Subject instructions
  • Subject lacks the capacity to consent
  • Medication that, in the opinion of the Provider, 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 in addition to microMend to close the outermost skin layer
  • Use of tissue adhesive or other adhesives directly over the wound

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Closure of lacerations with microMend

Laceration closure with microMend

Interventions

microMend

Wound closure product consisting of tan array of tiny metal Microstaples affixed to adhesive backing. The device is the size and shape of a butterfly closure and intended for closure of skin wounds.

Primary outcome measure

  • Wound closure results of skin wounds after healing [ Time Frame: 3 months ]
  • Overall assessment of microMend by Provider at end of the wound closure procedure. [ Time Frame: Day 0 ]
  • Time of wound closure. [ Time Frame: ay 0 ]
  • Subject's assessment of microMend. [ Time Frame: Day 0 ]
  • Subject's assessment of pain with application of microMend [ Time Frame: Day 10 ]

Central Contacts and Locations

Central contacts

Ronald Berenson, MD

206-790-1094rberenson@kitotechmedical.com

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

KitoTech Medical, Inc.

Last update posted

Feb 5, 2019

Last verified

Feb, 2019

Keywords

  • Lacerations
  • Wounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by KitoTech Medical, Inc. on 2019-02-05.