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

NCT03376620 | Completed Phase 3 DMC

• 1 other identifier: B2008:134
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertrophic Scar

Keywords

Prevention of hypertrophic scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Observer Objective Scar Assessment Scale ratings

  at least one year post operatively

Study Arms (2)

10% Urea cream

SHAM COMPARATOR

Opposite breast scars treated OD at hs simultaneously using sham 10% Urea cream

Drug: 10% Urea cream

Active cream with 1,4 diaminobutane

ACTIVE COMPARATOR

Other breast scar treated daily with active cream with 1,4 diaminobutane topically OD at hs

Drug: 1,4-Diaminobutane

Interventions

1,4-Diaminobutane DRUG

Daily application to surgical breast scars of 1,4 diaminobutane on the active side

Also known as: Fibrostat

Active cream with 1,4 diaminobutane

10% Urea cream DRUG

Daily application to surgical breast scars of 10% Urea cream on the sham side

10% Urea cream

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (1)

• 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.

  PMID: 31881614 DERIVED

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Putrescine

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Diamines; Polyamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Label number coded by manufacturer and released after blinding period
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blind Randomized Controlled Trial; Patient as their own control

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: September 2, 2011
• Primary Completion: August 13, 2013
• Study Completion: July 15, 2016
• Last Updated: December 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share