Randomized trial compares comprehensive margin assessment with standard pathology after melanoma surgery

The University of Nebraska is conducting a randomized study comparing two methods of examining tissue removed during wide local excision (WLE) for Stage I–II cutaneous melanoma, including acral melanoma. All participants undergo guideline-concordant surgery, but the excised tissue is processed differently. The experimental approach uses comprehensive peripheral and deep margin assessment (CPDMA), which examines the surgical margins more extensively, while the control uses conventional “breadloafing,” in which representative perpendicular tissue sections are examined. The primary endpoint is whether CPDMA detects a higher rate of positive peripheral margins, indicating melanoma cells at the edge of the removed tissue.

The planned 282-patient study also tracks whether differences in margin detection lead to more re-excisions, fewer local recurrences at one and two years, or greater pathology costs and processing time. Finding additional positive margins could help identify patients who need more surgery, but greater detection does not automatically mean fewer recurrences or better outcomes. Standard care remains WLE with histopathologic margin assessment and sentinel lymph node biopsy when indicated. This trial asks whether changing how removed tissue is examined can improve the completeness of treatment without creating unnecessary procedures or resource burdens.