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Design and implementation of an international multiarm, multistage master protocol for trials of complex traumatic
Corey B Bills1, Camille J Hochheimer, Samantha C Roberts
1Department of Emergency Medicine (C.B.B., J.P., S.S., V.S.B., S.K., S.A.T., A.A.G.); Department of Biostatistics, University of Colorado School of Medicine, Aurora, CO (C.J.H., S.C.R., L.B., N.E.C.); CNE Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk (R.F.); Municipal Non-profit Enterprise of Kharkiv Regional Council, Regional Cardiology Center, Kharkiv (O.V.O.); Municipal non-profit enterprise of Lviv Regional Council, First Territorial Medical Association of Lviv, St Panteleimon Hospital, Lviv (H.L.H.); Municipal Non-profit Enterprise of Dnipro City Council City Clinical Hospital No 4, Dnipro (O.V.A.); Municipal Non-profit Enterprise of Kyiv Regional Council, Kyiv Regional Clinical Hospital, Kyiv, Ukraine (N.A.B.); Center for Combat Medicine and Battlefield (COMBAT) Research, University of Colorado Anschutz Medical Campus, Aurora (V.S.B., S.K., A.A.G.); Denver Health, Department of Emergency Medicine, Denver, CO (S.A.T.).
Background:
Traumatic wound infections are a significant contributor to morbidity and mortality during war. Given challenges of performing clinical trials during war and the urgent need for interventions to prevent and treat infected traumatic wounds exacerbated by global increases in antimicrobial resistance, we developed the Prevention and Treatment Clinical Trials for Antimicrobial Resistance Research to Improve Outcomes of Traumatic Wounds in Ukraine (PACT-ARROW). We provide an overview of the protocol and implementation strategy.
Methods:
PACT-ARROW is a multiarm multistage (MAMS) platform designed to evaluate the safety, efficacy, and effectiveness of device and therapeutic interventions to optimize outcomes of patients hospitalized in Ukraine with acute traumatic wounds. The aim is to improve standard or available care with the possibility to study multiple interventions simultaneously. A platform steering committee will review potential interventions, determine alignment with the mission of the protocol, and promote those with sufficient evidence to warrant testing in a trial.
Results:
PACT-ARROW has undergone local and national ethics approval in the United States and Ukraine. We began with a prospective observational cohort (ARROW), with over 350 patients enrolled. A corresponding interventional trial, with a targeted enrollment of 150, just began enrollment. Expansion of interventions and target populations is planned.
Conclusions:
The intended benefits of the platform include standardized patient enrollment criteria, outcomes tailored to feasible data collection during active war, and improvements in patient care for the treatment of complex and infected traumatic wounds. The design is intended to apply to a broad set of interventions with relevant patient-centered outcomes, all while addressing challenges of performing clinical trials in a war environment. Future studies utilizing the PACT-ARROW master protocol are planned. ( J Trauma Acute Care Surg . 2026;101: S58-S65. Copyright © 2026 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Surgery of Trauma.).
Level Of Evidence:
Therapeutic/Care Management; Level V.
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