Low-cost Negative Pressure Wound Therapy vs Standard Dressings for Gustilo IIIb Tibial Fractures (Bukavu Pilot RCT) (BukavuNPWTRC)
25. August 2026 aktualisiert von: Tumusifu Manegabe Jean de Dieu, Université Catholique de Bukavu
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.
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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
66
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Prof. Dr. Olivier Cornu
- Telefonnummer: +32475387566
- E-Mail: olivier.cornu@saintluc.uclouvain.be
Studieren Sie die Kontaktsicherung
- Name: Prof. Paul Budema
- Telefonnummer: +243997698323
- E-Mail: paulbdma@yahoo.fr
Studienorte
-
-
South Kivu
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Bukavu, South Kivu, Demokratische Republik des Kongo, B.P.285
- Université Catholique de Bukavu
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Kontakt:
- Alain Kabakuli Namugusha PhD student
- Telefonnummer: +243997823626
- E-Mail: alainkabakuli@gmail.com
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Hauptermittler:
- Jean de Dieu Tumusifu Manegabe, PhD student
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Arm 1: Low-cost NPWT
Low-cost negative pressure wound therapy applied after debridement according to protocol
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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.
|
|
Aktiver Komparator: Arm 2: standard wound dressing
Conventional wound dressing applied after debridement according to protocol
|
Standard wound dressing applied after debridement for Gustilo type IIIb open tibia fractures, with dressing changes according to the study protocol
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number and percentage of participants meeting the prespecified feasibility criteria
Zeitfenster: From the start of recruitment through completion of the final follow-up assessment at 12 months after randomisation
|
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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Englebert, Professor, CH UCL Mont Godinne- Namur/Belgique
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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?
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Januar 2027
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
1. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
20. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. August 2026
Zuerst gepostet (Tatsächlich)
27. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RDC2026008
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Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
start date: After publication of the primary resultats End date: 12 months after publication
IPD-Sharing-Zugriffskriterien
Qualified reseachers who provide a scientififcally valid proposal and agree to data use terms
Art der unterstützenden IPD-Freigabeinformationen
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Studiendaten/Dokumente
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Einzelner Teilnehmerdatensatz
Informationskennung: To be assignedInformationskommentare: To be assigned upon publication
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Studienprotokoll
Informationskennung: To be assignedInformationskommentare: To be assigned upon publication
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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