Regenerative Vs Flap-Based Limb Salvage: A Multi-Centered, Prospective, Randomized Controlled Trial

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)

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.

Tweetable abstract

Comparison of flap-based reconstruction to regenerative limb salvage yields similar success rates for complex extremity wounds.

Keywords::

• dHACM
• flap reconstruction
• limb salvage
• regenerative medicine

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/rme-2022-0147

Author contributions

FH Lau: PI, treating physician, planning, internal funding acquisition, manuscript prep, data preparation, data analysis, draft editing. RD Hoffman: manuscript prep, data preparation, data analysis, draft editing. D Danos: statistical consultant, data preparation, data analysis, draft editing. R Torabi and CW Patterson: data preparation, data acquisition, draft editing. AD McKendrick: data preparation, data acquisition, trial coordination. M Stalder, C Dupin and H St. Hilaire: treating physician, data acquisition, draft editing.

Financial & competing interest disclosure

LSUHSC-NO Dean’s Clinical Research Enhancement Grant. Devices used: EpiFix (Mimedx), Adaptic (Acelity). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval from LSUHSC institutional review board (protocol number 9167) or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Presentations

This work has been presented at the following conferences:

Boswick International Burn and Wound Symposium, Jan 22-27 2022, Maui, Hawaii

AAPS Centennial Meeting, April 9-12 2022, San Diego, California

Data sharing statement

The authors certify that this manuscript reports original clinical trial data. The data will not be made publicly available.