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

Summary

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.

Conditions

• Open Tibia Fracture

Interventions

DEVICE

intervention2: standard wound dressing

Standard wound dressing applied after debridement for Gustilo type IIIb open tibia fractures, with dressing changes according to the study protocol

DEVICE

Intervention1: Low-cost NPWT

Low-cost NPWT :low-cost negative pressure therapy dressing applied after debridement for Gustilo type IIIb open tibia fractures, with dressing changes according to the study protocol.

Sponsors & Collaborators

• Université Catholique de Louvain

  collaborator OTHER

• Université Catholique de Bukavu

  lead OTHER

Principal Investigators

• Englebert, Professor · CH UCL Mont Godinne- Namur/Belgique

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• Democratic Republic of the Congo

Study Locations