Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty.
Subjects will undergo surgical excisions in the abdominoplasty area and will be treated with MRG-001 or placebo for 3 weeks. After 6 weeks, the excision area is harvested for analysis and the study is terminated and the abdominoplasty is performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
To evaluate the preliminary effectiveness of MRG-001 treatment on tensile strength of the scars. The difference in Newton force will be compared between saline and MRG-001.
Time frame: Week -6 to 0
Evaluate the safety and tolerability of MRG-001 treatment compared to placebo controls. The number of (serious) adverse events will be compared between MRG-001 and placebo
Time frame: Week -6 to 0
Evaluate the pharmacokinetics of MRG-001 (plerixafor and tacrolimus) in patients with wounds. The following parameters will be assessed: Maximum concentration, trough levels, Minimum concentrations, Clearance and half-life.
Time frame: Week -6 to 0
Evaluate the pharmacodynamics of wound healing with MRG-001 treatment by measuring the presence of stem cells and immune cells in the peripheral blood and granulation tissue compared to placebo controls.
Time frame: Week -6 to 0
Assess the time to full re-epithelization of the wounds assessed by digital photography by three independent plastic surgeons.
Time frame: Week -6 to 0
Assess the scar appearance by the modified POSAS (PI & Patient) at 6 weeks.
Time frame: Week -6 to 0
Assess the difference in VAS pain scores.
Time frame: Week -6 to 0
Incidence of wound infection requiring antibiotic therapy within 28 days after excision.
Time frame: Week -6 to 0
Assess the effect of MRG-001 on the histological presence of stem cells and immunoregulatory cells in the scars. The number of CD133+, CD34+ FOXP3+, Macrophages will be compared between MRG-001 and placebo in the wound area.
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Time frame: Week -6 to 0