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

NCT07790991 | Not Yet Recruiting DMC

• 1 other identifier: RDC2026008
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Open Tibia Fracture

Keywords

low cost NPWT; Standard dressing; Gustillo IIIb; tibia fracture; pilot RCT; Low ressource setting; Bukavu

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 dressing DEVICE

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 NPWT DEVICE

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.

Arm 1: Low-cost NPWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Catholique de Bukavu: lead
• Université Catholique de Louvain: collaborator

Study Sites (2)

Université Catholique de Bukavu

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

Location

Université Catholique de Bukavu

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

Location

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: 33292770 BACKGROUND

• 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.

  PMID: 40517847 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 42445811 BACKGROUND

• 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.

  PMID: 31855973 BACKGROUND

• 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.

  PMID: 28867644 BACKGROUND

• 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

  BACKGROUND

• 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?

  BACKGROUND

• 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.

  PMID: 21712704 BACKGROUND

• 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.

  PMID: 17003216 BACKGROUND

• 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.

  PMID: 26180719 BACKGROUND

• 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.

  PMID: 35491582 BACKGROUND

• 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.

  PMID: 32044942 BACKGROUND

• 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.

  PMID: 30573002 BACKGROUND

• Jain R, Sinha PR, Pathak PK. Comparison of Indigenous Low Cost Vacuum-Assisted Closure Therapy and Standard Wound Therapy in Open Fractures: A Randomized Controlled Trial. J Orthop Case Rep. 2026 Jan;16(1):421-428. doi: 10.13107/jocr.2026.v16.i01.6718.

  PMID: 41541432 BACKGROUND

• Griffin M, Malahias M, Khan W, Hindocha S. Update on the management of open lower limb fractures. Open Orthop J. 2012;6:571-7. doi: 10.2174/1874325001206010571. Epub 2012 Nov 30.

  PMID: 23248730 BACKGROUND

• Tissingh EK, Marais L, Loro A, Bose D, Paner NT, Ferguson J, Morgensten M, McNally M. Management of fracture-related infection in low resource settings: how applicable are the current consensus guidelines? EFORT Open Rev. 2022 May 31;7(6):422-432. doi: 10.1530/EOR-22-0031.

  PMID: 35638596 BACKGROUND

• Craxford S, Vris A, Ahluwalia R, Saini A, Harrison WD, Graham S, Sharma H. Fracture related infection in open tibial fractures. J Orthop. 2024 Jan 30;51:98-102. doi: 10.1016/j.jor.2024.01.010. eCollection 2024 May.

  PMID: 38357441 BACKGROUND

• Zalavras CG, Patzakis MJ. Open fractures: evaluation and management. J Am Acad Orthop Surg. 2003 May-Jun;11(3):212-9. doi: 10.5435/00124635-200305000-00008.

  PMID: 12828451 BACKGROUND

Related Links

• Not available at this moment

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Englebert, Professor

  CH UCL Mont Godinne- Namur/Belgique

  STUDY CHAIR

Central Study Contacts

Prof. Dr. Olivier Cornu

CONTACT

+32475387566; olivier.cornu@saintluc.uclouvain.be

Prof. Paul Budema

CONTACT

+243997698323; paulbdma@yahoo.fr

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

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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

Locations

DE (2)