AzTrials
AzTrials

Open Tibia FractureBukavuNPWTRCNCT07790991

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

A study testing intervention2: standard wound dressing and Intervention1: Low-cost NPWT in people with Open Tibia Fracture, run by Université Catholique de Bukavu at 2 sites in Democratic Republic of the Congo.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open Tibia Fracture
What is being tested?
intervention2: standard wound dressing and Intervention1: Low-cost NPWT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesDemocratic Republic of the Congo
Study dates
1 Jan 2027to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • diabetes mellitus,
  • peripheral vascular disease,
  • vascular injury requiring repair,
  • chronic steroid use,
  • coagulopathies,
  • cancer;
Show all 15Show fewer
  • open fractures older than 3 days;
  • fractures previously operated on;
  • chronic osteomyelitis;
  • primary amputation,
  • immunosuppression,
  • multiple fractures,
  • polytrauma,
  • pregnancy;
  • preexisting dermatological conditions.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Prof. Dr. Olivier Cornu contact

+32475387566

olivier.cornu@saintluc.uclouvain.be

Prof. Paul Budema contact

+243997698323

paulbdma@yahoo.fr

Democratic Republic of the Congo2 sites

  • Université Catholique de Bukavu

    Bukavu, South Kivu, B.P.285

    Alain Kabakuli Namugusha PhD student, +243997823626, alainkabakuli@gmail.com

    Jean de Dieu Tumusifu Manegabe, PhD student

  • Université Catholique de Bukavu

    Bukavu, South Kivu, B.P.285

Other trials in Democratic Republic of the Congo

About this study

Official title: 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.

Read more

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.
Read the detailed description
  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.

Being tested
intervention2: standard wound dressing, Intervention1: Low-cost NPWT
Keywords
low cost NPWT, Standard dressing, Gustillo IIIb, tibia fracture, pilot RCT, Low ressource setting, Bukavu
Medical subject headings
Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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 groups in NCT07790991
Study groupRoleWhat they receive
Arm 1: Low-cost NPWTExperimentalLow-cost negative pressure wound therapy applied after debridement according to protocol
Receives: Device: Intervention1: Low-cost NPWT
Arm 2: standard wound dressingActive comparatorConventional wound dressing applied after debridement according to protocol
Receives: Device: intervention2: standard wound dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the start of recruitment through completion of the final follow-up assessment at 12 months after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07790991
Sponsor's protocol ID
RDC2026008
Acronym
BukavuNPWTRC
Status last verified
Aug 2026
First submitted
20 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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

  • 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.

    PubMed 33292770

  • 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.

    PubMed 40517847

  • 18. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS Consensus Group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi:10.1136/bmj.i5239. 19. Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023;9(1):59. doi:10.1186/s40814-023-01291-5.

  • Fonkoue L, Tissingh EK, Marais LC, Malaba M, Abrha K, Ferguson J, Morgenstern M, Cornu O, Laubscher M, Buzisa Mbuku R, Galiwango GW, Botman M, Wojno J, Majigo MV, Martin C Jr, Harrison WJ, Schade AT, Marenah K, Nyamutora M, Namale PE, Mdingi V, McNally M. Management of fracture-related infection in low-resource settings in Africa: recommendations and guidelines from an international expert group. J Bone Jt Infect. 2026 Jul 9;11(4):401-411. doi: 10.5194/jbji-11-401-2026. eCollection 2026.

    PubMed 42445811

  • Govaert GAM, Kuehl R, Atkins BL, Trampuz A, Morgenstern M, Obremskey WT, Verhofstad MHJ, McNally MA, Metsemakers WJ; Fracture-Related Infection (FRI) Consensus Group. Diagnosing Fracture-Related Infection: Current Concepts and Recommendations. J Orthop Trauma. 2020 Jan;34(1):8-17. doi: 10.1097/BOT.0000000000001614.

    PubMed 31855973

  • Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24.

    PubMed 28867644

  • 14. Ferreira N, Tsang Shao-Ting J, Jansen van Rensburg A, Venter R, Epstein GZ. Unexpected high prevalence of Gram-negative pathogens in fracture-related infection: is it time to consider extended Gram-negative cover antibiotic prophylaxis in open fractures?. SA Orthop. J. 2023 ;22(3):146-150. http://www.scielo.org.za/scielo.php?script=sci_arttext&pid=S1681-150X2023000300006&lng=en. https://doi.org/10.17159/2309-8309/2023/v22n3a5

  • 12. American College of Surgeons. Advanced Trauma Life Support: Student Course Manual. 10th ed. Chicago, IL: American College of Surgeons; 2018 13. Guidelines for infection control and prevention in anaesthesia in South Africa. South Afr J Anaesth and Analg 2021;27{4):1-55}. Doi/10.36303/SAJAA.2021.27.4.S1. https://journals.co.za/doi/10.36303/SAJAA.2021.27.4.S1?

  • Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.

    PubMed 21712704

  • Webb LX, Dedmond B, Schlatterer D, Laverty D. The contaminated high-energy open fracture: a protocol to prevent and treat inflammatory mediator storm-induced soft-tissue compartment syndrome (IMSICS). J Am Acad Orthop Surg. 2006;14(10 Spec No.):S82-6. doi: 10.5435/00124635-200600001-00019.

    PubMed 17003216

  • Chaput B, Garrido I, Eburdery H, Grolleau JL, Chavoin JP. Low-cost Negative-pressure Wound Therapy Using Wall Vacuum: A 15 Dollars by Day Alternative. Plast Reconstr Surg Glob Open. 2015 Jul 8;3(6):e418. doi: 10.1097/GOX.0000000000000347. eCollection 2015 Jun.

    PubMed 26180719

  • Costa ML, Achten J, Parsons NR; WOLLF collaborators. Five-year outcomes for patients sustaining severe fractures of the lower limb : mid-term results from the Wound management for Open Lower Limb Fracture (WOLLF) trial. Bone Joint J. 2022 May;104-B(5):633-639. doi: 10.1302/0301-620X.104B5.BJJ-2021-1568.R2.

    PubMed 35491582

  • Costa ML, Achten J, Knight R, Bruce J, Dutton SJ, Madan J, Dritsaki M, Parsons N, Fernandez M, Grant R, Nanchahal J; WHIST Trial Collaborators. Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on Deep Surgical Site Infection After Surgery for Lower Limb Fractures Associated With Major Trauma: The WHIST Randomized Clinical Trial. JAMA. 2020 Feb 11;323(6):519-526. doi: 10.1001/jama.2020.0059.

    PubMed 32044942

  • Costa ML, Achten J, Bruce J, Davis S, Hennings S, Willett K, Petrou S, Jeffery S, Griffin D, Parker B, Masters J, Lamb SE, Tutton E, Parsons N. Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture: the WOLLF RCT. Health Technol Assess. 2018 Dec;22(73):1-162. doi: 10.3310/hta22730.

    PubMed 30573002

Questions about this trial

What is this clinical trial studying?

A study testing intervention2: standard wound dressing and Intervention1: Low-cost NPWT in people with Open Tibia Fracture, run by Université Catholique de Bukavu at 2 sites in Democratic Republic of the Congo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof. Dr. Olivier Cornu (+32475387566, olivier.cornu@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and percentage of participants meeting the prespecified feasibility criteria (time frame: From the start of recruitment through completion of the final follow-up assessment at 12 months after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07790991, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in