Low-cost Negative Pressure Wound Therapy vs Standard Dressings for Gustilo IIIb Tibial Fractures (Bukavu Pilot RCT)

1. Recruitment rate during the recruitment period Recruitment rate will be calculatedas the number of participants randomised per month from the beginning to the end ofthe recruitment period. The result will be reported as the total number ofparticipants recruited, the duration of the recruitment period and the mean numberof participants recruited per month. 2. Proportion of eligible participants who provide informed consent This measure willbe calculated as the number of eligible participants who provide informed consentdivided by the total number of eligible participants approached. The result will bereported as a number and percentage. 3. Proportion of randomised participants who receive the assigned intervention Thismeasure will be calculated as the number of randomised participants who receive theintervention to which they were allocated divided by the total number of randomisedparticipants. The result will be reported as a number and percentage overall andseparately for each treatment group. 4. Proportion of participants adhering to the assigned wound‐management protocolAdherence will be assessed according to the prespecified protocol requirements forlow‐cost negative pressure wound therapy or standard wound dressings. The resultwill be reported as the number and percentage of participants meeting theprespecified adherence criteria in each treatment group. 5. Proportion of randomised participants completing the prespecified follow‐upassessments This measure will be calculated as the number of randomised participantswho complete the prespecified follow‐up assessments divided by the total number ofrandomised participants. The result will be reported as a number and percentageoverall and by treatment group. 6. Completeness of clinical outcome data at the final follow‐up assessment Datacompleteness will be calculated as the number of required outcome assessmentscompleted divided by the total number of outcome assessments expected according tothe study protocol. The result will be reported as a percentage, overall andseparately for each treatment group.Clinical outcomes will be considered exploratory outcomes. They will be summarised usingthe prespecified clinical measures and will not be used to draw definitive conclusionsregarding treatment effectiveness in this pilot trial.