NCT03830515

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

February 2, 2019

Last Update Submit

February 2, 2019

Conditions

LacerationsWounds

Keywords

LacerationsWounds

Outcome Measures

Primary Outcomes (5)

  • Wound closure results of skin wounds after healing

    Assessment of photographs of wounds closed with microMend at Monthg 3 by independent physician with experience in assessing skin wounds.

    3 months

  • Overall assessment of microMend by Provider at end of the wound closure procedure.

    Questionnaire on opinion of Provider (Physician, PA, or Nurse Practitioner on usability and other characteristics of microMend

    Day 0

  • Time of wound closure.

    Measurement of time in seconds to close wound with microMend devices.

    ay 0

  • Subject's assessment of microMend.

    Measurement of pain upon placement of microMend using VAS scoring system

    Day 0

  • Subject's assessment of pain with application of microMend

    Questionnaire regarding evaluation of microMend

    Day 10

Study Arms (1)

Closure of lacerations with microMend

EXPERIMENTAL

Laceration closure with microMend

Device: microMend

Interventions

microMendDEVICE

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.

Also known as: microMend Skin Closure Device
Closure of lacerations with microMend

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

  • Nizami T, Beaudoin F, Suner S, Aluisio A, Bhatt RA, Jay GD. Evaluation of microMend wound closure device in repairing skin lacerations. Emerg Med J. 2023 Aug;40(8):564-568. doi: 10.1136/emermed-2022-212667. Epub 2023 May 23.

    PMID: 37220958DERIVED

MeSH Terms

Conditions

LacerationsWounds and Injuries

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Berenson, MD

CONTACT

206-790-1094rberenson@kitotechmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A single arm open label study testing the ability of microMend to close lacerations.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

April 20, 2018

Primary Completion

October 31, 2019

Study Completion

December 31, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)