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|Title:||A pilot randomized controlled trial of nanocrystalline silver dressing against manuka honey dressing and conventional dressing in healing diabetic foot ulcer||Authors:||Tsang, Ka Kit||Degree:||Ph.D.||Issue Date:||2016||Abstract:||INTRODUCTION: One of the common complications of diabetes is diabetic foot ulcer (DFU). Some individuals receive multiple surgeries and even amputation. Up to now, there is no gold standard for the topical treatment of DFU. Among all topical interventions, the use of nanocrystalline silver (nAg) and manuka honey (MH), which have similar effects in terms of antibacterial and anti-inflammatory actions, is becoming more widespread. Based on the literature, there is no evidence on using nAg so the effect of nAg dressing on DFU healing is unknown. STUDY AIMS: There were two study aims in this pilot study. The first one was to test the feasibility of the study design and the acceptability of the interventions. The secondary one was to test the preliminary effect of nAg dressing against MH and conventional dressings on DFU healing. METHODS: This study was an open-label randomized controlled trial using a three-group design: i) nAg with alginate (the experimental group); ii) MH with alginate (the comparison group); iii) conventional dressing (paraffin tulle) (the control group). A total of 31 eligible participants (11 in the nAg group, 10 in the MH group and 10 in the conventional group) were recruited after they had been discharged from two hospitals and from one GOPD which are all under the operation of Hospital Authority. The inclusion criteria included living in community settings, being type 2 DM patients, being aged 40 or over and having a foot ulcer larger than 1 cm in diameter and located at or below the malleolar region of the foot. The exclusion criteria included HbA1c level ≥ 10%, an ankle brachial index ≤ 0.4, an ulcer exposing bone or joint, osteomyelitis, severe wound infection, known allergy to the tested materials, known case of venous ulcer, tumor or autoimmune disease. All the participants received the interventions in an orthopedic nurse clinic of a regional hospital (hospital A). Each participant visited the clinic once each week in the first 4 weeks and then once every two weeks from the 5th to 12th week of this study. In each clinic visit, the student investigator carried out the specialized nursing care, which included patient education on self-care management in diabetic control and foot care, providing off-loading method, cleaning the wound and sharp debridement as well as applying the topical dressings to each participant according to the group allocation. The outcomes for preliminary effect of nAg included the proportion of complete healing; ulcer size reduction; the concentration of biochemical markers [total protein, matrix metalloproteinase-9 (MMP-9), tumor necrosis factor-alpha (TNF-α) and interleukin-1 alpha (IL-1α)] in wound fluid, bacteriology; and severity of wound infection. All study outcomes were assessed in each clinic visit, except the concentration of biochemical markers that were assessed within the first 4 weeks. In the feasibility and acceptability tests, the comments and feedback from the participants, research assistants and intervention providers were collected. In addition, the student investigator also self-reflected and self-reviewed on the whole study process.
RESULTS: Some issues were identified from the feasibility and acceptability tests and they were required to improve in the main study. These feasibility issues included inappropriate and inadequate numbers of study centers, non-blinding of group allocation on collection and analysis of wound fluid, insufficient frequency and long duration of clinic visit, insufficient length of trial period, lengthy education session, inadequate pain control on sharp debridement, inadequate skills of research assistants and inappropriate instrument for outcome measures. In the acceptability issues, the unsatisfactory adherence of on foot care and off-loading in middle-aged participants and the possible barriers to these issues were also identified. The result on preliminary effect of nAg showed that the percentages of participants who experienced complete ulcer healing and ulcer size reduction were the highest in nAg group (nAg > MH > conventional groups) but there was no significant difference among the three groups. Besides, there was no significant difference in concentration of total protein, MMP-9, TNF-α and IL-1α than MH and conventional dressing groups in MMP-9 concentration among groups. The concentration of all biomarkers did not align with the ulcer healing in terms of ulcer size reduction. There was no obvious trend of concentration changes of all biomarkers. In bacteriology and severity of wound infection, there were also no differences among groups. The major reasons for the insignificant results included small sample size as well as specialized nursing care on foot care and serial sharp debridement that further reduced the differences among groups. In addition, the short duration of observation period in wound fluid analysis may result in the non-alignment of clinical and laboratory outcomes. CONCLUSION: To conclude, it was the first pilot trial to explore the feasibility, acceptability and preliminary effect of nAg on DFU. The preliminary test this study included clinical and laboratory data, both results triangulated together to address the study objectives. This study approach extended the scope of nursing research in wound care. This pilot study contributed to the preparation of future main study and as a reference of other similar studies and also the potential development of evidence-based nursing clinical practice. The recommendations to address the issues identified from the feasibility and acceptability tests would improve the internal and external validity of the main study. Overall, the present study result served as a foundation of the study design of future main study and other similar studies.
|Subjects:||Foot -- Ulcers.
Diabetes -- Complications -- Treatment.
Hong Kong Polytechnic University -- Dissertations
|Pages:||xxii, 319 pages : color illustrations|
|Appears in Collections:||Thesis|
View full-text via https://theses.lib.polyu.edu.hk/handle/200/8815
Citations as of May 15, 2022
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