The objective of the study is to evaluate the safety and preliminary efficacy of MF-4181, a hydrogel scaffold, in improving scars and their resulting consequences following abdominoplasty or laparoscopy/laparotomy gynecologic procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care.
Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care.
II Katedra i Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, Poland
Klinika Ginekologii Operacyjnej
Lublin, Poland
Klinika Ginekologii i Ginekologii Onkologicznej
Warsaw, Poland
Safety, defined as the absence of device related serious adverse events at 3 months post last MF-4181 treatment
Time frame: 3 Months
Investigator and Subject Observer Scar Assessment Scale (POSAS)
Time frame: 12 months
Investigator and Subject Anchored Visual Analog Scar Evaluation Scale
Time frame: 12 Months
Digital photographs evaluated by independent medical experts
Time frame: 12 Months
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