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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01438125
First received: September 20, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Scars
Other: MF-4181
Other: Standard surgical wound closure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Halscion, Inc.:

Primary Outcome Measures:
  • Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator and Subject Observer Scar Assessment Scale (POSAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Investigator and Subject Anchored Visual Analog Scar Evaluation Scale [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Digital photographs evaluated by independent medical experts [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: standard surgical wound closure

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438125

Locations
Poland
II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, Poland
Klinika Ginekologii Operacyjnej
Lublin, Poland
Klinika Ginekologii i Ginekologii Onkologicznej
Warsaw, Poland
Sponsors and Collaborators
Halscion, Inc.
Investigators
Principal Investigator: Wlodzimierz Baranowski, MD Unaffliated
  More Information

No publications provided

Responsible Party: Halscion, Inc.
ClinicalTrials.gov Identifier: NCT01438125     History of Changes
Other Study ID Numbers: HAL-0082
Study First Received: September 20, 2011
Last Updated: March 28, 2013
Health Authority: Poland: Ethics Committee

ClinicalTrials.gov processed this record on November 24, 2014