Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients
Condition: Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): 1,4-Diaminobutane; 10% Urea cream
Intervention type(s): Drug; Drug
Intervention description(s): Daily application to surgical breast scars of 1,4 diaminobutane on the active side; Daily application to surgical breast scars of 10% Urea cream on the sham side
Other intervention name(s): Fibrostat
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind Randomized Controlled Trial; Patient as their own control
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention of hypertrophic scar