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

Role of Topical Putrescine (Fibrostat) in 10%Urea (TFU) for Prevention of Hypertrophic Scars in Mammoplasty Patients

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scar
• Intervention / Treatment: Drug: 10% Urea cream; Drug: 1,4-Diaminobutane

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: Undergoing breast reduction surgery -

Exclusion Criteria: Not pregnant or lactating

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Fibrostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duredness of scar at post treatment time frame for active versus control breast	Surface deformational force in grams of scar tissue in each of the treated breasts	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Observer Objective Scar Assessment Scale ratings	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.	at least one year post operatively

Collaborators and Investigators

• Sponsor: University of Manitoba

Publications and helpful links

General Publications

• Dolynchuk KN, Tredget EE. A Preliminary Report of the Biochemical and Clinical Effects of 1,4-Diaminobutane on Prevention of Human Hypertrophic Scars. Plast Reconstr Surg. 2020 Jan;145(1):76e-84e. doi: 10.1097/PRS.0000000000006413.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2011
• Primary Completion (Actual): August 13, 2013
• Study Completion (Actual): July 15, 2016

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Prevention of hypertrophic scar
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
• Other Study ID Numbers: B2008:134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No