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

NCT01438125 | Completed Phase 2

• 1 other identifier: HAL-0082
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Scars

Outcome Measures

Primary Outcomes (1)

• Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment

  3 Months

Secondary Outcomes (3)

• 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

Study Arms (2)

MF-4181

ACTIVE COMPARATOR

Scar halves randomized to treatment with device, opposite side treated per standard of care

Other: MF-4181

Standard surgical wound closure

ACTIVE COMPARATOR

Other: Standard surgical wound closure

Interventions

MF-4181 OTHER

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.

Also known as: Hydrogel scaffold

MF-4181

Standard surgical wound closure OTHER

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Halscion, Inc.: lead

Study Sites (3)

II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii

Lublin, Poland

Location

Klinika Ginekologii Operacyjnej

Lublin, Poland

Location

Klinika Ginekologii i Ginekologii Onkologicznej

Warsaw, Poland

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wlodzimierz Baranowski, MD

  Unaffliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 21, 2011
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

PL (3)