MedTrace Logo

A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

NCT03688880 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2020-08-20

Study results available
· View outcomes & findings →

Summary

This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (\<=)15 centimeter (cm). Eligible participants were randomized 2:1 to MAR-CUTIS or Dermabond Advanced.

Conditions

  • Wounds and Injuries
  • Lacerations
  • Surgical Incision

Interventions

DEVICE

MAR-CUTIS

MAR-CUTIS was applied in 1 to 2 mm thick layer, ensuring that at least 1 cm of the glue was applied over the length of the wound on each side. The amount of the glue applied was calculated such that one 5-mL syringe covers approximately 8 cm of wound length (giving a total of 10 cm per syringe). For wounds \>8 cm, 2 syringes were required.

DEVICE

Dermabond Advanced

Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions, taking care not to apply adhesive between the wound edges.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2019-07-17
Completion
2019-09-04
FDA Device
Yes

Countries

  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688880 on ClinicalTrials.gov