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

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.

Study Overview

• Status: Completed
• Conditions: Scars
• Intervention / Treatment: Other: MF-4181; Other: Standard surgical wound closure

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland
    • II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii
  • Lublin, Poland
    • Klinika Ginekologii Operacyjnej
  • Warsaw, Poland
    • Klinika Ginekologii i Ginekologii Onkologicznej

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects between 18 and 60 years of age undergoing abdominoplasty without intraoperative flexion at time of skin excision OR female subjects between 18 and 60 years of age undergoing diagnostic and/or operative laparoscopy/laparotomy gynecologic procedures.
• Weight between 50 and 95 kg with BMI between 20 and 30
• Able and willing to give written informed consent
• Willing to comply with the follow-up schedule

Exclusion Criteria:

• Need of concomitant surgical procedures that would be performed at the same time as the index surgical procedure or that would influence the healing process
• Previous abdominal surgery with scars or adhesions that would limit or complicate the index surgical procedure
• Presence of ventral or umbilical hernia requiring the use of prosthetic material
• Heart disease
• Pregnant or planning to become pregnant during the course of the study; the exception to this exclusion is if ectopic pregnancy is the reason for the procedure
• History of coagulopathy or bleeding disorder
• An American Society of Anesthesiologists (ASA) Score of >II
• Known diabetes
• Current or history of heavy smoking (i.e., 10 pack years)
• Active skin disorder or other condition that may interfere with healing or history of such a condition
• Planned use of an ON-Q® pain control device (I-Flow Corporation, Lake Forest, CA) or similar incisional intervention post index procedure
• Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarteritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura
• Anticipated use of DERMABOND® or another topical skin adhesive type of wound closure
• Unwilling or unable to return for follow-up visits
• Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated
• Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic
• Unable or unwilling to follow post-operative instructions
• Known hypersensitivity to MF-4181, dextran, or any of its constituent materials
• Previous participation in this study to avoid multiple enrollments of an individual subject.
• Chemotherapy or hormone therapy for cancer within the last 3 months, or probability that these treatments will be required during the 6 months of study participation.
• Current or past radiation therapy in the abdominal incision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MF-4181; Scar halves randomized to treatment with device, opposite side treated per standard of care	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 Names: Hydrogel scaffold
Active Comparator: Standard surgical wound closure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator and Subject Observer Scar Assessment Scale (POSAS)	12 months
Investigator and Subject Anchored Visual Analog Scar Evaluation Scale	12 Months
Digital photographs evaluated by independent medical experts	12 Months

Collaborators and Investigators

• Sponsor: Halscion, Inc.
• Investigators: Principal Investigator: Wlodzimierz Baranowski, MD, Unaffliated

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: HAL-0082