Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients
|ClinicalTrials.gov Identifier: NCT03376620|
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Scar||Drug: 1,4-Diaminobutane Drug: 10% Urea cream||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||56 participants|
|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|
|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|
|Actual Primary Completion Date :||August 13, 2013|
|Actual Study Completion Date :||July 15, 2016|
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
Daily application to surgical breast scars of 1,4 diaminobutane on the active side
Other Name: Fibrostat
- 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
- 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.