Comparison of Regenerative Limb Salvage to Flap-based Reconstruction of Complex Extremity Wounds: 
A Randomized Control Trial

Ryan D. Hoffman1; Denise Danos PhD2, Ann McKendrick3, Hugo St. Hilaire MD DDS3, Mark Stalder MD3, Charles Dupin MD3,  Frank H. Lau MD, FACS3

School of Medicine1, Department of Behavior and Community Health2, Department of Plastic and Reconstructive Surgery3 

Louisiana State University Health Sciences Center, New Orleans, LA  

Introduction 

Extremity wounds with exposed critical structures (e.g. including periosteum-stripped bone, paratenon-stripped tendon) may lead to amputation unless durable soft tissue coverage is achieved. 

Flap-based limb salvage (fLS) is the standard of care but 

requires:

An alternative technique is regenerative limb salvage (rLS) using dehydrated human amnion/chorion membrane (dHACM) + skin grafting

Specific Aim 

The goal of this study was to compare rLS to fLS in a multi-centered, prospective, randomized controlled trial (RCT) with a crossover option upon reconstructive failure

Methods

IRB approved multicenter prospective RCT enrolling patients from 2016 and 2018

48 subjects with complex extremity wounds ( > 1 exposed critical structure)

Exclusion criteria: malignancy, exposed hardware, poor lap candidates (ischemic limb, PVD) 

Patients were randomized to fLS or rLS in a 1:2 ratio

Primary outcomes included: