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Trial record 1 of 1 for:    kitotech | United States
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Evaluation of microMend Device to Close Lacerations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830515
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
KitoTech Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Lacerations Wounds Device: microMend Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single arm open label study testing the ability of microMend to close lacerations.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of microMend Device to Close Skin Wounds Associated With Repair of Lacerations
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Closure of lacerations with microMend
Laceration closure with microMend
Device: 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.
Other Name: microMend Skin Closure Device




Primary Outcome Measures :
  1. Wound closure results of skin wounds after healing [ Time Frame: 3 months ]
    Assessment of photographs of wounds closed with microMend at Monthg 3 by independent physician with experience in assessing skin wounds.

  2. Overall assessment of microMend by Provider at end of the wound closure procedure. [ Time Frame: Day 0 ]
    Questionnaire on opinion of Provider (Physician, PA, or Nurse Practitioner on usability and other characteristics of microMend

  3. Time of wound closure. [ Time Frame: ay 0 ]
    Measurement of time in seconds to close wound with microMend devices.

  4. Subject's assessment of microMend. [ Time Frame: Day 0 ]
    Measurement of pain upon placement of microMend using VAS scoring system

  5. Subject's assessment of pain with application of microMend [ Time Frame: Day 10 ]
    Questionnaire regarding evaluation of microMend



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830515


Contacts
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Contact: Ronald Berenson, MD 206-790-1094 rberenson@kitotechmedical.com

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Francesca Beaudoin, MD, PhD         
Sponsors and Collaborators
KitoTech Medical, Inc.
Brown University
Investigators
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Principal Investigator: Francesca Beaudoin, MD, PhD Department of Emergency Medicine, Walpert School of Medicine, Brown University
Principal Investigator: Gregory Jay, MD, PhD Department of Emergency Medicine, Walpert School of Medicine, Brown University

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Responsible Party: KitoTech Medical, Inc.
ClinicalTrials.gov Identifier: NCT03830515    
Other Study ID Numbers: KTM005
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by KitoTech Medical, Inc.:
Lacerations
Wounds
Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries