Clinical trial NCT01438125: MF-4181 for the Reduction of Scars Secondary to Abdominoplasty or Laparoscopy/Laparotomy Gynecologic Procedures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scars
Lead sponsor: Halscion, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment
timeFrame: 3 Months
Secondary outcomes:
measure: Investigator and Subject Observer Scar Assessment Scale (POSAS)
timeFrame: 12 months
measure: Investigator and Subject Anchored Visual Analog Scar Evaluation Scale
timeFrame: 12 Months
measure: Digital photographs evaluated by independent medical experts
timeFrame: 12 Months
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii
city: Lublin
country: Poland
facility: Klinika Ginekologii Operacyjnej
city: Warsaw
country: Poland
facility: Klinika Ginekologii i Ginekologii Onkologicznej
Study officials:
affiliation: Unaffliated
name: Wlodzimierz Baranowski, MD
role: PRINCIPAL_INVESTIGATOR
References: