The prevalence of chronic and complex wounds is high in low- and middle-income countries (LMICs). Due to the lack of adequate treatment wound conditions are likely to worsen. Improving access to wound care in LMICs is crucial for enhancing the quality of life for the people living there. Vacuum- assisted closure (VAC) therapy is an effective treatment for chronic and complex wounds. By applying a negative pressure to the wound the healing process is promoted. However, due to the high cost of VAC devices, their availability in LMICs is limited. A. Knulst works as a biomedical engineer at GPH and recognized this problem. In GPH the AquaVAC, a converted aquarium pump, is used to be able provide VAC therapy to patients. The use of the AquaVAC is not meeting the users’ requirements. Recognizing this problem, A. Knulst initiated the WOCA project to develop a VAC device tailored for LMICs. Over the past three years, the project has progressed to creating three simple yet functional prototypes using locally available materials in GPH. Based on the findings of A. Knulst a suitable next step for the WOCA is determined to conduct a clinical trial to evaluate the WOCA’s effectiveness in wound healing.
Designing the goal of this graduation project; preparation of the WOCA for the performance of a clinical trial conducted in GPH. Based on analysation of this goal preparation of the WOCA consists of veri- fication, and validation of the design requirements, verification of the applicable ISO-criteria, and the performance of a risk assessment. By making a redesign the current WOCA at GPH will also be made compatible with these stated requirements.
By making a redesign during this graduation project the canister is implemented and the noise is re- duced for the WOCA. This new version of the WOCA is verified for its design requirements as well as validated, also the applicable ISO-norms are verified and a risk assessment is performed.
Based on this performed effort it is shown that the WOCA is exceeding the allowed noise level deter- mined to be reached before the WOCA can start the clinical trial. Furhtermore, recommendations have been given for additional validation and verification of the WOCA before conducting the clinical trial.
Steps have been taken during this graduation project to improve the access to wound care in LMICs by a contribution to the open-source-publication of the WOCA device, and the development of a study protocol for the performance of a clinical trial.