There is a significant need for trials that evaluate the treatment of University of Texas (UT) grade 2 and 3 diabetic foot ulcers (bone, joint, or tendon exposed wounds). We undertook a trial looking at the effect of intact fish skin graft (IFSG) on these deep and difficult-to-heal ulcers. 262 patients Intent to Treat (ITT) patients with UT grade 2 and 3 DFUs were randomised to receive intact fish skin graft (IFSG) or a standardised treatment (SOC) that adhered to the International Working Group on the Diabetic Foot (IWGDF) guidelines. The secondary endpoints that were measured included wound area reduction (WAR), healing rates at 20 and 24 weeks; closure rates by UT grade, perfusion, quality of life, pain reduction and IFSG safety. We report ITT (all randomised) (mITT previosly reported) The (WAR) at 12 weeks was 65.53% for IFSG versus 30.82% for SOC (p = 0.007). UT 2 wounds (60% of total) exhibited a closure rate of 47% versus 23% at 16 weeks for IFSG versus SOC (p = 0.0033). Target wound infections were comparable (39 vs. 37) and major outcomes were comparable during the 24 week period (target-limb amputations 8% vs. 7%). Time-to-heal favoured IFSG (restricted mean to 24 weeks 17.31 vs. 19.37 weeks; KM/log-rank significant; Cox HR 1.59). The in the treatment of deep complex diabetic foot wounds the addition of IFSG significantly improved the number of patients with total wound closure as well as the time to wound closure without increased risk of complications. This improvement in total wound closure and time to wound closure was noted across prior amputation status, quality of perfusion, and UT grade.
Some intensive care unit (ICU) patients develop an extremely deep and sustained immunosuppression that increases the risk of secondary infections and can ultimately compromise survival. Thanks to an easily accessible and simplified immune monitoring to identify immunological failure, a personalised immune restoration approach is now feasible. Among the different therapeutic strategies in this field, interferon gamma (IFN-) is probably the most interesting drug to reduce the burden of secondary infections in the ICU.
This is a two parallel group multicentre blinded add-on randomised trial comparing immunorestoration by subcutaneous injection of IFN- to standard of care in targeted ICU patients. The study will be performed in 23 ICUs in France. Patients hospitalised in the ICU for a week, with multiple organ failure defined by a sequential organ failure assessment score ≥6 during this first week, will be enrolled. If within 96 hours after inclusion, these patients express immunosuppressed features defined by a low absolute lymphocyte count (x109/L) and low expression of human leucocyte antigen-DR (HLA-DR) on monocytes (13 500 antibodies bound per cell and an absolute lymphocyte count >1200 x109/L) at day 10, healthcare costs at day 90 and rate of serious adverse reactions and suspected unexpected serious adverse reaction at day 90. We plan to randomise 326 patients.
The study will be implemented in accordance with European regulations and was independently reviewed and approved by the French Ethics Committee Comité de Protection des Personnes Ile de France III (EUCT number: 2024-516780-93-00). The results will be reported in international peer-reviewed journals and presented at international and national conferences.
by Michele Letitia Tchabou Tientcheu, Pierre Marie Kaktcham, Edith Marius Foko Kouam, Laverdure Tchamani Piame, Lysette Chabrone Djodjeu Kamega, Aarzoo , Agnihotri Shekhar, Singh Bhim Pratap, François Zambou Ngoufack
Conventional culture media such as de Man, Rogosa and Sharpe are essential for the growth of lactic acid bacteria and the production of metabolites used in the food and pharmaceutical industries. However, their high cost limits their application, particularly in low and middle-income countries. This study aimed to develop a cost-effective and efficient culture medium based on agro-industrial and environmental by-products, pineapple peels, sugarcane molasses, and black soldier fly larvae cake. After physico-chemical analysis of the by-products, excluding sugarcane molasses, a statistical mixture design was used to determine the optimal proportions for supporting lactic acid bacteria growth and bacteriocin production. Growth and metabolite production were monitored via plate count and agar well diffusion assays respectively. The strains tested belonged to the genera Lactobacillus, Bifidobacterium, Streptococcus, Lactococcus, and Bacillus as an out taxa group. The larvae cake showed high protein (48.47 ± 0.14%) and amino acid (17 types) content, while pineapple peels and molasses were rich in carbohydrates (89.52 ± 0.16% and 86.86 ± 0.07%). Based on regression models, the compromise formulation was defined as 55.15% larvae cake hydrolysate, 19.85% pineapple peel hydrolysate, and 25.00% sugarcane molasses. This medium highly supported lactic acid bacteria growth (9.43–9.86 log CFU/mL) compared to MRS and M17 (9.20–9.69 log CFU/mL), with Lactobacillus strains performing better. It also supported bacteriocin activity (11.0–14.5 mm inhibition zones), higher or similar to MRS and M17, with Lactococcus lactis subsp. lactis MA2 exhibiting the strongest effect. These results highlight the potential of this formulation as a sustainable, low-cost alternative for microbiology and biotechnology, particularly in resource-limited settings. The determination of its formula will allow its manufacture once the proximate compositions of the ingredients are known, regardless their origin. Future investigations will focus on optimisation of culture conditions, powder form formulation, and cost evaluation.To evaluate and compare documentation completeness of HIV-related data by age group (children, adolescents and adults) in Haiti’s Electronic Medical Record (EMR) system.
Cross-sectional evaluation.
EMR data for 36 965 enrolment visits, and 123 608 return visits from 58 facilities in Haiti (from 2016 to 2022).
Children, adolescents and adults accessing HIV care and treatment services in Haiti.
Health facility attendance for HIV-related healthcare.
Level of data completeness, as a measure of data quality. We developed Composite Completeness Scores (CCS scores) to measure data completeness. Lower scores meant lower completeness. Generalised linear models were used to investigate factors associated with completeness.
At the enrolment visit, most patients were adults (81.6%) and female (56.7%). Most facilities were health centres (75.9%). The overall average enrolment visit CCS score was 54.0%. At enrolment, being a child (CCS score difference=–7.08, 95% CI: –11.31 to –2.86) and a more recent year of enrolment (–6.01, 95% CI: –11.69 to –0.33) were significantly associated with lower completeness scores than being an adult and having an earlier year of enrolment, respectively. The overall average return visit CCS score was 49.6%. At the return visit, children (–6.76, 95% CI: –10.07 to –3.45) had significantly lower average completeness scores than adults. For first viral load documentation, children had lower odds of completeness compared with adults (adjusted OR=0.21, 95% CI: 0.16 to 0.28). Sex, year of enrolment, facility ownership (public, private, mixed), total patient volume and duration of EMR use were not significantly associated with completeness of documentation at the enrolment and return visits.
We observed disparities in electronic data completeness by age group, which may be indicative of digital health disparities. Documentation was particularly poor among children and declined over time for enrolment visits. Further research is needed to understand and address these documentation gaps.