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Randomized Controlled Trial
. 2023 Mar;18(3):207-218.
doi: 10.2217/rme-2022-0147. Epub 2023 Feb 16.

Regenerative vs flap-based limb salvage: a multi-centered, prospective, randomized controlled trial

Frank H Lau  1 , Ryan D Hoffman  2 , Denise Danos  3 , Radbeh Torabi  4 , Charles W Patterson  5 , Ann D McKendrick  1 , Mark Stalder  1 , Charles Dupin  1 , Hugo St Hilaire  1
Affiliations
Randomized Controlled Trial

Regenerative vs flap-based limb salvage: a multi-centered, prospective, randomized controlled trial

Frank H Lau et al. Regen Med. 2023 Mar.

Abstract

Aim: The goal of this study was to compare success rates of a regenerative limb salvage approach (rLS) using dehydrated human chorion amnion membrane (dHACM) to traditional flap-based limb salvage (fLS). Materials & methods: This prospective RTC enrolled patients presenting with complex extremity wounds over a 3-year period. Primary outcomes included success of primary reconstruction, persistence of exposed structures, time to definitive closure, and time to weight bearing. Results: Patients meeting inclusion criteria were randomized to fLS (n = 14) or rLS (n = 25). The primary reconstructive method was successful for 85.7% of fLS subjects and 80% of rLS subjects (p = 1.00). Conclusion: This trial provides strong evidence that rLS is an effective option in the setting of complex extremity wounds, with success rates comparable to traditional flaps. Clinical Trial Registration: NCT03521258 (ClinicalTrials.gov).

Keywords: dHACM; flap reconstruction; limb salvage; regenerative medicine.

Plain language summary

Chronic and traumatic wounds may result in loss of limb without appropriate medical treatment. Traditionally large wounds with exposed bone or other important structures require surgery to transfer healthy soft tissue (a tissue flap) from one area of the body to the defect created by the wound. Our study seeks to demonstrate an approach to similar wounds using a biologic dressing to avoid extensive surgery. We demonstrate that this biologic dressing made from human membranes has a similar success rate to flap surgery for achieving wound healing.

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