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

Scars Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438125
• Other study ID #: HAL-0082
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: March 28, 2013
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: Halscion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scars

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii	Lublin
Poland	Klinika Ginekologii Operacyjnej	Lublin
Poland	Klinika Ginekologii i Ginekologii Onkologicznej	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Halscion, Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment		3 Months	Yes
Secondary	Investigator and Subject Observer Scar Assessment Scale (POSAS)		12 months	No
Secondary	Investigator and Subject Anchored Visual Analog Scar Evaluation Scale		12 Months	No
Secondary	Digital photographs evaluated by independent medical experts		12 Months	No