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Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients

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ClinicalTrials.gov Identifier: NCT03376620
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. This was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score data for quality of scar formation.

Condition or disease Intervention/treatment Phase
Hypertrophic Scar Drug: 1,4-Diaminobutane Drug: 10% Urea cream Phase 3

Detailed Description:

In this study, patients were "randomized" into one of 2 study groups described below. They agreed to being treated on the right side or the left with active agent, while the other side was to receive inactive cream. The active molecule is called Fibrostat or 1,4 diaminobutane and is a naturally occurring inhibitor of scar formation. The inactive jar contains the vehicle alone without Fibrostat.

The patients received both cream types to be applied to the appropriate side assigned by the randomization process, one numbered jar each per breast in the order and amount as explained in detail by the patient educator. The cream was applied daily and in the same order, one jar for the right and the other jar for the left consistently. The randomization was performed at the factory with an assigned number recorded on each jar and the jar contents listed and recorded with its assigned number. Each jar of active cream is randomly assigned with another jar of inactive cream to form a pair which were both given to the patient. The cream in both jars looks and smells the same. Neither the patient nor the study doctor knew which breast as receiving the active agent. In an emergency, this information was to be made available.

Participation in the study was for 12 weeks. the patients were seen for photos and scar testing using a painless surface testing device called a Rex® durometer at 1, 3, 6, and 12 weeks post op.

The researcher could decide to take patients off this study if a patient were to develop a rash during the run-in period of 1 week from the cream on either side.

The patients could stop participating at any time. However, this was usually accompanied by a valid reason such as lack of transportation to regular follow up appointments. No serious effects were seen and the only patients to stop participation in the study except 1 which was lost to follow-up could be accounted for. The results were revealed to patients at the completion of the 12 week trial.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind Randomized Controlled Trial; Patient as their own control
Masking: Double (Participant, Investigator)
Masking Description: Label number coded by manufacturer and released after blinding period
Primary Purpose: Prevention
Official Title: Role of Topical Putrescine (Fibrostat) in 10%Urea (TFU) for Prevention of Hypertrophic Scars in Mammoplasty Patients
Actual Study Start Date : September 2, 2011
Primary Completion Date : August 13, 2013
Study Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Sham Comparator: 10% Urea cream
Opposite breast scars treated OD at hs simultaneously using sham 10% Urea cream
Drug: 10% Urea cream
Daily application to surgical breast scars of 10% Urea cream on the sham side
Active Comparator: Active cream with 1,4 diaminobutane
Other breast scar treated daily with active cream with 1,4 diaminobutane topically OD at hs
Drug: 1,4-Diaminobutane
Daily application to surgical breast scars of 1,4 diaminobutane on the active side
Other Name: Fibrostat


Outcome Measures

Primary Outcome Measures :
  1. Duredness of scar at post treatment time frame for active versus control breast [ Time Frame: 12 weeks ]
    Surface deformational force in grams of scar tissue in each of the treated breasts


Secondary Outcome Measures :
  1. Patient Observer Objective Scar Assessment Scale ratings [ Time Frame: at least one year post operatively ]
    Validated scale of scar outcome based on seven parameters graded on a scale of 1-10 ranked lowest to highest in severity. Patient was the "observer" in this study making subjective parameters listed such as pain and itch a direct patient correlate rather than one recorded by a second-person observation.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Undergoing breast reduction surgery -

Exclusion Criteria: Not pregnant or lactating

More Information

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03376620     History of Changes
Other Study ID Numbers: B2008:134
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Manitoba:
Prevention of hypertrophic scar

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes