METHODS AND ANALYSIS: This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants.
ETHICS AND DISSEMINATION: The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.
TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trials Number (ISRCTN17842822).
METHODS: A prospective, randomized, single-blinded control trial was performed on eligible diabetic patients with full-thickness cavity wounds. Patients' demographics, size and site of wounds, and baseline routine blood investigations were recorded. The wounds were dressed every other day with Kelulut honey for the intervention group or gel for the control group. The wound size reduction and granulation tissue formation percentage were calculated every 6 days for 1 month.
RESULTS: Seventy-one patients were randomized. After 30 days of follow-up, 62 participants were available for analysis: 30 from the control group and 32 from the treatment group. The control group had increased granulation tissue at baseline and more wounds on the lower limb and posterior trunk. Both groups showed an increasing mean and median percentage of wound epithelialization and granulation tissue over time, with significantly higher values at every timepoint in the honey group (p
METHODS: A total of 20 methanolic crude extracts (bark and leaf) from ten different plants were screened using a colorimetric hyaluronidase enzymatic assay. The active plant extract (Payena dasyphylla) was then studied for its hyaluronidase inhibitory activity in the interleukin-1β (IL-1β) stimulated human chondrocytes cell line (NHAC-kn) using zymography method. The Payena dasyphylla methanolic bark extract was then fractionated into several fractions in where the ethyl acetate (EA) fraction was evaluated for its inhibitory effects on the HYAL1 and HYAL2 gene expressions using reverse transcription-polymerase chain reaction (RT-PCR) technique. While the MMP-3 and MMP-13 protein expressions were evaluated using western blot method. The phenolic and flavonoid contents of the three fractions as well as the antioxidant property of the EA fraction were also evaluated.
RESULTS: Bark extract of Payena dasyphylla (100 μg/ml) showed the highest inhibitory activity against bovine testicular hyaluronidase with 91.63%. The plant extract also inhibited hyaluronidase expression in the cultured human chondrocyte cells in response to IL-1β (100 ng/ml). Similarly, treatment with Payena dasyphylla ethyl acetate (EA) fraction (100 μg/ml) inhibited the HYAL1 and HYAL2 mRNA gene expressions as well as MMP-3 and MMP-13 protein expression in a dose dependent manner. Payena dasyphylla EA fraction has demonstrated the highest amount of phenolic and flavonoid content with 168.62 ± 10.93 mg GAE/g and 95.96 ± 2.96 mg RE/g respectively as compared to water and hexane fractions. In addition, the Payena dasyphylla EA fraction showed strong antioxidant activity with IC₅₀ value of 11.64 ± 1.69 μg/mL.
CONCLUSION: These findings have shown that Payena dasyphylla might contained potential phenolic compounds that inhibiting the key enzyme in osteoarthritis development, which is the hyaluronidase enzyme through interruption of HYAL1 and HYAL1 gene expressions. The degradation of cartilage could also be inhibited by the plant through suppression of MMP-3 and MMP-13 protein expressions. We also reported that the inhibitory effect of Payena dasyphylla on hyaluronidase activity and expression might be due to its anti-oxidant property.
Methods: This multicentre randomised controlled trial included 244 patients, of whom 86 were treated with chitosan derivative film and 84 with hydrocolloid. The percentage of epithelisation, as well as patient comfort, clinical signs, and patient convenience in application and removal of the dressings were assessed.
Results: The primary outcome of this study was the percentage of epithelisation. Except for race (p = 0.04), there were no significant differences between groups in sex, age, antibiotic usage, or initial wound size (p > 0.05). There was no significant difference in the mean epithelisation percentage between groups (p = 0.29). Patients using chitosan derivative film experienced more pain during removal of dressing than those in the hydrocolloid group (p = 0.007). The chitosan derivative film group showed less exudate (p = 0.036) and less odour (p = 0.024) than the control group. Furthermore, there were no significant differences between groups in terms of adherence, ease of removal, wound drainage, erythema, itchiness, pain, and tenderness. No oedema or localised warmth was observed during the study.
Conclusion: This study concluded that chitosan derivative film is equivalent to hydrocolloid dressing and can be an option in the management of superficial and abrasion wounds.
Clinical trial No: NMRR-11-948-10565.