NCT03688880

A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced

A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS With Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15 Centimeters

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-07-17
• Completion: 2019-09-04
• First posted: 2018-09-28
• Last updated: 2020-08-20
• Results posted: 2020-08-20

Locations

19 sites across 4 countries: France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated device study