ScarsPhase 2NCT01438125
MF-4181 for the Reduction of Scars Secondary to Abdominoplasty or Laparoscopy/Laparotomy Gynecologic Procedures
A Phase 2 study testing MF-4181 and Standard surgical wound closure in people with Scars, run by Halscion, Inc. at 3 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scars
- What is being tested?
- MF-4181 and Standard surgical wound closure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesPoland
- Study dates
- Feb 2009to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii
Lublin
Klinika Ginekologii Operacyjnej
Lublin
Klinika Ginekologii i Ginekologii Onkologicznej
Warsaw
About this study
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
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
- Being tested
- MF-4181, Standard surgical wound closure
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF-4181Other
Also called Hydrogel scaffold
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 closureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MF-4181 | Active comparator | Scar halves randomized to treatment with device, opposite side treated per standard of care Receives: Other: MF-4181 |
| Standard surgical wound closure | Active comparator | Not described Receives: Other: Standard surgical wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment
Measured: 3 Months
Secondary outcomes (3)
Investigator and Subject Observer Scar Assessment Scale (POSAS)
Measured: 12 months
Investigator and Subject Anchored Visual Analog Scar Evaluation Scale
Measured: 12 Months
Digital photographs evaluated by independent medical experts
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halscion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wlodzimierz Baranowski, MD, Principal investigator, Unaffliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438125
- Sponsor's protocol ID
- HAL-0082
- Status last verified
- Mar 2013
- First submitted
- 20 Sep 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01438125
- Acronym / sponsor ID
- HAL-0082
- Conditions
- Scars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Halscion, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MF-4181 | Active comparator | Other: MF-4181Scar halves randomized to treatment with device, opposite side treated per standard of care |
| Standard surgical wound closure | Active comparator | Other: Standard surgical wound closure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF-4181Also: Hydrogel scaffoldSurgical 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 | MF-4181 |
| Standard surgical wound closureSurgical 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 | Standard surgical wound closure |
Primary outcome
Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment
Time frame: 3 Months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wlodzimierz Baranowski, MD principal investigator
Unaffliated
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MF-4181 and Standard surgical wound closure in people with Scars, run by Halscion, Inc. at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.