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

Low-cost Negative Pressure Wound Therapy Versus Standard Wound Dressings for Gustilo-Anderson Type IIIb Open Tibial Fractures in a Low-resource Setting: Protocol for a Pilot Randomised Controlled Trial in Bukavu,Democratic Republic of Congo

Negative-pressure wound therapy (NPWT) is widely used in the management of acute and chronic wounds, but commercial systems are costly and may be inaccessible in low-resource settings. This pilot randomised controlled trial will assess the feasibility of a future definitive multicentre trial comparing a locally developed low-cost NPWT system with standard wound dressings in adults with Gustilo-Anderson type IIIb open tibial fractures.

Methods and analysis: Adults aged ≥18 years presenting to the Department of Orthopaedics and Traumatology of the Hôpital Provincial Général de Référence de Bukavu between 1 January and 31 December 2027, within 72 hours of sustaining an open tibial fracture, will be screened. Final eligibility will be confirmed after initial surgical debridement; patients with Gustilo-Anderson type IIIb injuries will be randomised 1:1 to low-cost NPWT or standard wound dressings. A pragmatic sample of 66 participants (33 per group) is planned.

The pilot is not powered for clinical effectiveness. Feasibility outcomes will include recruitment, consent, intervention delivery and fidelity, crossover and discontinuation, retention, data completeness and safety. Prespecified progression criteria will inform the design of a future definitive multicentre trial.

All randomised participants will be analysed according to the intention-to-treat principle. Clinical outcomes will be exploratory, with fracture-related infection within 3 months as the main exploratory clinical outcome. Effect estimates will be reported with 95% confidence intervals, with emphasis on magnitude and precision rather than formal hypothesis testing.

Ethics and dissemination: The study has been approved by the Ethics Committee of the Université Catholique de Bukavu (UCB/CIES/PB/GM/012/2026) and will be conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. Written informed consent will be obtained before randomisation. Results will be disseminated through peer-reviewed publications, scientific meetings, and accessible summaries for participants and the local clinical community.

Strengths and limitations of this study

• This pilot randomised controlled trial will provide prospective evidence on the feasibility of evaluating a locally developed low-cost negative pressure wound therapy system for Gustilo-Anderson type IIIb open tibial fractures in a resource-limited setting.
• Random allocation with concealed allocation and blinded assessment of fracture-related infection and digital wound measurements, where feasible, will reduce important sources of bias.
• Prespecified feasibility outcomes and progression criteria will inform the design, sample size, recruitment strategy and outcome-assessment procedures of a future definitive multicentre randomised controlled trial.
• The single-centre design and small pragmatic sample size limit the generalisability of the findings and preclude definitive conclusions regarding the clinical effectiveness of low-cost negative pressure wound therapy.
• The nature of the interventions prevents blinding of participants and treating clinicians, and limited access to some diagnostic investigations may affect the completeness of fracture-related infection assessment.

1. Recruitment rate during the recruitment period Recruitment rate will be calculated as the number of participants randomised per month from the beginning to the end of the recruitment period. The result will be reported as the total number of participants recruited, the duration of the recruitment period and the mean number of participants recruited per month.
2. Proportion of eligible participants who provide informed consent This measure will be calculated as the number of eligible participants who provide informed consent divided by the total number of eligible participants approached. The result will be reported as a number and percentage.
3. Proportion of randomised participants who receive the assigned intervention This measure will be calculated as the number of randomised participants who receive the intervention to which they were allocated divided by the total number of randomised participants. The result will be reported as a number and percentage overall and separately for each treatment group.
4. Proportion of participants adhering to the assigned wound-management protocol Adherence will be assessed according to the prespecified protocol requirements for low-cost negative pressure wound therapy or standard wound dressings. The result will be reported as the number and percentage of participants meeting the prespecified adherence criteria in each treatment group.
5. Proportion of randomised participants completing the prespecified follow-up assessments This measure will be calculated as the number of randomised participants who complete the prespecified follow-up assessments divided by the total number of randomised participants. The result will be reported as a number and percentage overall and by treatment group.
6. Completeness of clinical outcome data at the final follow-up assessment Data completeness will be calculated as the number of required outcome assessments completed divided by the total number of outcome assessments expected according to the study protocol. The result will be reported as a percentage, overall and separately for each treatment group.

Clinical outcomes will be considered exploratory outcomes. They will be summarised using the prespecified clinical measures and will not be used to draw definitive conclusions regarding treatment effectiveness in this pilot trial.

Inclusion Criteria:

• All adult patients (age ≥18 years)
• admitted at orthopedic and trauma departement
• between 1 January 2027 and 31 December 2027,
• within 72 hours of sustaining an open tibial fracture Gustilo IIIb
• before and after debridement

Exclusion Criteria:

• diabetes mellitus,
• peripheral vascular disease,
• vascular injury requiring repair,
• chronic steroid use,
• coagulopathies,
• cancer;
• open fractures older than 3 days;
• fractures previously operated on;
• chronic osteomyelitis;
• primary amputation,
• immunosuppression,
• multiple fractures,
• polytrauma,
• pregnancy;
• preexisting dermatological conditions.