NCT01438125

MF-4181 for the Reduction of Scars Secondary to Abdominoplasty or Laparoscopy/Laparotomy Gynecologic Procedures

A Pilot Study to Evaluate the Safety and Preliminary Efficacy of MF-4181 for the Reduction of Scars Secondary to Abdominoplasty or Laparoscopy/Laparotomy Gynecologic Procedures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Halscion, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a hydrogel scaffold, in improving scars and their resulting consequences following abdominoplasty or laparoscopy/laparotomy gynecologic procedures.

Conditions

• Scars

Interventions

Type	Name	Description
OTHER	MF-4181	Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care.
OTHER	Standard surgical wound closure	Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care.

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-09-21
• Last updated: 2013-03-29

Locations

3 sites across 1 country: Poland