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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:
ClinicalTrials.gov Identifier:
NCT01438125
First Posted: September 21, 2011
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Halscion, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Investigator and Subject Observer Scar Assessment Scale (POSAS) [ Time Frame: 12 months ]
  • Investigator and Subject Anchored Visual Analog Scar Evaluation Scale [ Time Frame: 12 Months ]
  • Digital photographs evaluated by independent medical experts [ Time Frame: 12 Months ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Halscion, Inc.
ClinicalTrials.gov Identifier: NCT01438125     History of Changes
Other Study ID Numbers: HAL-0082
First Submitted: September 20, 2011
First Posted: September 21, 2011
Last Update Posted: March 29, 2013
Last Verified: March 2013