Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients
NCT ID: NCT03376620
Last Updated: 2017-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2011-09-02
2016-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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10% Urea cream
Opposite breast scars treated OD at hs simultaneously using sham 10% Urea cream
10% Urea cream
Daily application to surgical breast scars of 10% Urea cream on the sham side
Active cream with 1,4 diaminobutane
Other breast scar treated daily with active cream with 1,4 diaminobutane topically OD at hs
1,4-Diaminobutane
Daily application to surgical breast scars of 1,4 diaminobutane on the active side
Interventions
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1,4-Diaminobutane
Daily application to surgical breast scars of 1,4 diaminobutane on the active side
10% Urea cream
Daily application to surgical breast scars of 10% Urea cream on the sham side
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
18 Years
80 Years
FEMALE
Yes
Sponsors
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University of Manitoba
OTHER
Responsible Party
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References
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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.
Other Identifiers
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B2008:134
Identifier Type: -
Identifier Source: org_study_id