An interventional study of intervention2: standard wound dressing and Intervention1: Low-cost NPWT in Open Tibia Fracture, sponsored by Université Catholique de Bukavu. Not yet recruiting at 2 sites in Democratic Republic of the Congo. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Université Catholique de Bukavu · Not applicable, Interventional, and Treatment
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
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.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's planned enrollment of 66 is close to the median of 65 across 91 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →This is the only study on the registry with Université Catholique de Bukavu as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Low-cost negative pressure wound therapy applied after debridement according to protocol
Device: Intervention1: Low-cost NPWT
Conventional wound dressing applied after debridement according to protocol
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
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.
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.
Time frame: From the start of recruitment through completion of the final follow-up assessment at 12 months after randomisation
Plan to share: Yes — De- indentified individual participant data will be shared with qualified reseachers upon reasonable resultats. Data sharing will occur in compliance with applicable ethical and regularitory requirements.
Supporting information: Study protocol, Clinical study report
Time frame: start date: After publication of the primary resultats End date: 12 months after publication
Access criteria: Qualified reseachers who provide a scientififcally valid proposal and agree to data use terms
Data sharing details ↗ · www.hpgrbukavu.org
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's planned 11 months is below that.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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