The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
Princess Margaret Hospital
Nassau, The Bahamas
Device safety
Device safety is defined as the incidence of device related adverse events.
Time frame: 6 months
Device efficacy
Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
Time frame: 12 months
Device efficacy
Volume and linear measurements will be taken by the investigator
Time frame: 12 months
Device efficacy
Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
Time frame: 12 months
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