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Brief 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.

Outcome Measures

Primary Outcomes (1)

Number and percentage of participants meeting the prespecified feasibility criteria
Feasibility will be assessed using prespecified criteria related to recruitment, informed consent, receipt of the assigned intervention, adherence to the assigned wound-management protocol, completion of follow-up assessments and completeness of outcome data. Each criterion will be reported as the number and percentage of participants meeting the criterion. Recruitment will additionally be summarised as the number of participants randomised per month during the recruitment period. Results will be reported overall and separately for the low-cost negative pressure wound therapy and standard wound-dressing groups. Clinical outcomes will be considered exploratory and will not be used to draw definitive conclusions regarding treatment effectiveness.
From the start of recruitment through completion of the final follow-up assessment at 12 months after randomisation

Study Arms (2)

Arm 1: Low-cost NPWT

EXPERIMENTAL

Low-cost negative pressure wound therapy applied after debridement according to protocol

Device: Intervention1: Low-cost NPWT

Arm 2: standard wound dressing

ACTIVE COMPARATOR

Conventional wound dressing applied after debridement according to protocol

Device: intervention2: standard wound dressing

Interventions

intervention2: standard wound dressingDevice

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

Arm 2: standard wound dressing

Intervention1: Low-cost NPWTDevice

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.

Study Sites (2)

Université Catholique de Bukavu

Bukavu, South Kivu, B.P.285, Democratic Republic of the Congo

Alain Kabakuli Namugusha PhD studentCONTACT+243997823626 alainkabakuli@gmail.com

Jean de Dieu Tumusifu Manegabe, PhD studentPRINCIPAL INVESTIGATOR

Université Catholique de Bukavu

Bukavu, South Kivu, B.P.285, Democratic Republic of the Congo

Related Publications (20)

22. Tumusifu JDD, Englebert A, Kabakuli A, AFRICA-NPWT Group, Buziza-Mbuku R, Schubert T, Tissingh E, Cornu O. Modified Delphi consensus recommendations for the use of negative-pressure wound therapy in orthopedic trauma and complex wounds in low- and middle-income countries: an African consensus study. Injury, 2026; JINJ-D-26-02123R1, accepted

BACKGROUND

Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w.

PMID: 33292770BACKGROUND

Sousa F, Zhu M, Farlie MK, Haines T, Borrelli B, Carroll C, Mathews C, Ribeiro DC, Fritz JM, Underwood M, Foster NE, Lamb SE, Sanchez ZM, Malliaras P. Guidance for intervention fidelity in nondrug, nonsurgical trials: a scoping review. J Clin Epidemiol. 2025 Sep;185:111868. doi: 10.1016/j.jclinepi.2025.111868. Epub 2025 Jun 13.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

The statistician conducting the primary feasibility and exploratory clinical analyses will also remain blinded to treatment allocation until the main analysis dataset has been finaliz

Purpose

TREATMENT

Intervention Model

PARALLEL

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Medical Doctor

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm 1: Low-cost NPWT

Arm 2: standard wound dressing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (20)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

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Data Sharing

Available IPD Datasets

Source record

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm 1: Low-cost NPWT

Arm 2: standard wound dressing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (20)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Available IPD Datasets

Source record

Locations