Implementation of quality and risk management strategies in wound care trials


  • Brianna M. Krafcik Department of Surgery, Boston University Medical Center, Boston, MA,
  • Marina Malikova Department of Surgery, Boston University Medical Center, Boston, MA,



Quality control, Process improvement, Risk management, Development of corrective and preventive actions (CAPA), Wound care trials


Background: Systematic analysis of risk factors in multiple wound care clinical trials was performed to develop proactive risk mitigation strategies and improve the quality of trials conducted.

Methods: This internal, single center internal quality control (QC) audit of eight recently completed prospective, randomized wound care clinical trials assessed the rate of serious adverse events (SAEs) and compared two wound indications: diabetic foot ulcers (DFU) and venous leg ulcers (VLU).  Additionally, adherence to study protocol and compliance with current regulatory requirements was examined based on the rate of protocol deviations over time.

Results: A comparison of SAE occurrences between DFU and VLU studies showed twice as many SAEs per subject in the DFU studies as compared to the VLU studies. The most common categories were infections, both of the wound and of other anatomic locations. The onboarding of new study coordinators and multiple coordinators working independently on one trial over time consistently showed an increase in the number of deviations per active subject, particularly immediately following the date of hire. The most common categories for deviations were out-of-window visits and missed study procedures.  

Conclusions: Assessment of potential issues in prospective wound care studies can lead to earlier mitigation of risks, quality improvement in data obtained and increased efficiency of studies conducted in this field. Effective training and retention of research coordinators can reduce the number of deviations, and an understanding of the frequency and types of adverse events can provide an expectation for those conducting trials in a particular indication.


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Original Research Articles