Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHO-recommended Wound Management in West Africa

NCT03957447 | Unknown

• 1 other identifier: WOUNDCAREV2
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The project rolls out combined innovative low-tech thermotherapy with heat packs and WHO recommended wound management in a Buruli ulcer (BU)-endemic district of West Africa. It addresses three key areas of considerable clinical and public health importance in the region:

• to better help people managing the disabling disease BU that primarily affects children in West Africa
• to implement WHO recommended general wound management for all types of wounds with tools available at the peripheral level of the health care system
• to prevent systemic life threatening sequelae (e.g. sepsis and rheumatic fever) and permanent local damage (e.g. motor and sensory disability) by early recognition and treatment of wounds at the community level. The project translates available research findings already validated on the secondary health care level into clinical practice at the periphery (primary health care level). The string of the investigator's previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary skills, tools and documents to immediately proceed into practical community application. Operational endpoints are
• coverage and quality of WHO recommended wound management training of health care personnel at the primary health care level (health posts);
• coverage, success rate and quality of care for patients with BU and other wounds; denominator controlled at health post level and high-quality Health and Demographic Surveillance Systems (HDSS) data. The project is embedded into a stable multidisciplinary working environment at Côte d'Ivoire, including an HDSS with a longstanding record of partnership and successful community-based operational research. The project builds on the principles laid out by the Sustainable Development Goals (SDGs) and Universal Health Coverage (UHC) and
• targets all patients with a broken down skin barrier independent of the cause (patient centred health care)
• brings diagnosis and treatment close to the community
• educates and trains both community members and health care workers
• measures the health intervention outcome The project is fully in line with the new integrated strategy for the skin NTDs of WHO's Department of Control of NTDs (WHO/NTD).

Conditions

Skin Ulcer; Buruli Ulcer; Nontuberculous Mycobacteria

Keywords

skin wounds; Ivory Coast community health services; prevalence study; thermotherapy

Outcome Measures

Primary Outcomes (7)

• Prevalence of skin ulcers in inhabitants of the Taabo health district, Ivory Coast

  To measure the frequency and the severity of skin lesions (broken skin barrier) in the community and the health services

  2 years

• Qualitative description of factors determining public health services-based skin ulcer managment

  Description of facilitating and obstructive factors for recognition and treatment of ulcers (questionnaires, interviews, patient and institution-related documentation of costs)

  2 years

• Frequency and severity of skin ulcers after community health service intervention

  To measure the impact of the wound management intervention (main study and substudy 1) on the frequency, spectrum and severity of wounds including systemic complications in the community and at the health posts / district hospital compared To the baseline study before intervention and over time after implementation of the intervention.

  2 years

• Number of patients with healed skin ulcers identified in the survey (see outcome 1)

  To measure the proportion of ulcers healed at each cycle of clinical diagnosis and corresponding presumptive treatment

  2 years

• Number of patients presenting at the health posts level with skin ulcers identified in the survey (see above)

  To describe the clinical epidemiology of different types of skin ulcers (wounds) presented (presumptive clinical and confirmed diagnoses)

  2 years

• Quality of care for patients with skin ulcers identified in the survey (see above)

  Coverage and quality of skin ulcer (wound) management training of health care personnel at the peripheral health care level (health posts)

  2 years

• Outcome of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study

  Number of patients completing thermotherapy exhibiting no more signs of clinically Buruli ulcer (BU) specific features' according to WHO guidelines or 'wound closure' within 6 months after completion of heat treatment ("primary cure") and 'absence of BU recurrence for 12 months after completion of heat treatment' ("definite cure").

  2 years

Secondary Outcomes (3)

• Drop out rate of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy

  2 years

• Withdrawal of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy

  2 years

• Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy

  2 years

Study Arms (3)

patients exhibiting skin wounds

Within the framework of Taabo HDSS Cross-sectional community and health services surveys are performed before wound management intervention (main study and substudy 1) is implemented (baseline) and are continued at 6 monthly intervals thereafter. Surveys are done door-to-door. All patients with skin lesions (broken skin barrier) are enrolled, lesions are documented with help of a questionnaire and photographic documentation.

patients identified in the survey and willing to participate

Each patient with a wound will be enrolled. Presumptive clinical diagnosis and empirical treatment, as well wound assessment, will be recorded at enrollment and at each follow-up visit. Additional laboratory testing done within the framework of the local health system will also be recorded.

patients exhibiting Buruli ulcers < 2cm

Buruli ulcer patients fulfilling inclusion criteria will be offered thermotherapy instead of standard antibiotic treatment. Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.

Other: thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia

Interventions

thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia OTHER

Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.

patients exhibiting Buruli ulcers < 2cm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Taabo Health District (HDSS), Ivory Coast Survey All HDSS population members Wound management study Patients with wounds defined as broken skin barrier. Thermotherapy study Buruli ulcer patients of the main study with ulcers \< 2cm.

You may qualify if:

• Survey All HDSS population members Wound management study Patients with wounds defined as broken skin barrier. Thermotherapy study Buruli ulcer patients of the main study with ulcers \< 2cm.

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Centre Suisse de Recherches Scientifiques en Cote d'Ivoire: collaborator
• Institut Pasteur de Côte d'Ivoire, Abidjan Cocody CHU, Côte d'Ivoire: collaborator

Study Sites (1)

CSRS

Abidjan, 1303, Côte d’Ivoire

RECRUITING

Related Publications (2)

• Toppino S, Koffi DY, Kone BV, N'Krumah RTAS, Coulibaly ID, Tobian F, Pluschke G, Stojkovic M, Bonfoh B, Junghanss T. Community-based wound management in a rural setting of Cote d'Ivoire. PLoS Negl Trop Dis. 2022 Oct 13;16(10):e0010730. doi: 10.1371/journal.pntd.0010730. eCollection 2022 Oct.

  PMID: 36227844 DERIVED

• Toppino S, N'Krumah RTAS, Kone BV, Koffi DY, Coulibaly ID, Tobian F, Pluschke G, Stojkovic M, Bonfoh B, Junghanss T. Skin wounds in a rural setting of Cote d'Ivoire: Population-based assessment of the burden and clinical epidemiology. PLoS Negl Trop Dis. 2022 Oct 13;16(10):e0010608. doi: 10.1371/journal.pntd.0010608. eCollection 2022 Oct.

  PMID: 36227839 DERIVED

MeSH Terms

Conditions

Skin Ulcer; Buruli Ulcer; Hyperthermia

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marija Stojkovic, MD

  University Hospital Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bassirou Bonfoh, PhD

CONTACT

+22507078083; mailto:bassirou.bonfoh@csrs.ci

Thomas Junghanss, MD

CONTACT

+491634270831; Thomas.Junghanss@urz.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Writer/Data Entry Supervisor

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: May 7, 2019
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

CÔ (1)