Nanosilver has great potential to replace povidone iodine for wound disinfection
Foot ulcers are a common surgical problem in India due to the habit of walking barefoot, coupled with the increased prevalence of diabetes. Treatment of chronic foot ulcers remains an ongoing surgical and medical challenge. Wound healing is a complex process of inflammation, growth factor proliferation, angiogenesis, and tissue & matrix remodeling, with the ultimate goal of rapid recovery with minimal scarring and maximum functions. Many topical formulations have played an important role in wound management, of which Povidone iodine and silver have long been known for their antibacterial properties. Nanotechnology has made available pure nanosilver with a higher surface area to volume ratio, thus providing better antibacterial efficacy and less toxicity.
PREPARATION AND METHODS
From November 2014 to May 2016, a total of 60 patients with chronic diabetic foot ulcers were admitted to this tertiary care hospital, 30 patients were randomized to the Povidone iodine dressing group and 30 patients in the Nano silver group, to compare the time taken to form granulation tissue, time to complete healing, length of hospital stay and total treatment cost.
RESULTS
The patients encountered in this study were between the 4th and 6th decades of life with a prominent male predominance (83% in Povidone iodine and 67% in Nano silver). All sores peel off, so a cotton swab should be taken to check the sensitivity of the culture. A reduction in flaking and granulation was observed at the end of each week up to 6 weeks of dressing change, with a favorable higher healing result seen in the Nano silver group from the 2nd week of the dressing (17% vs. %). The hospital stay was shorter in the silver Nano group. (Mean difference 6.63 days) and treatment costs were also significantly less in patients using Nano silver (Mean difference was 3416 INR about 47 USD).
CONCLUSION
A faster appearance of granulation tissue and preparation for skin grafting was seen in the Nanosilver group. The length of hospital stay and the overall cost of treatment are also lower, so the silver nano band can be considered a better option than Povidone iodine in the safe and rapid management of patients with chronic leg ulcers due to the disease diabetes.
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BACKGROUND
Diabetes is the leading cause of non-traumatic lower limb amputation, a common complication of untreated chronic foot or leg ulcers. Diabetic foot ulcers are full-thickness penetration of the dermis and the severity of the ulcer is usually graded using Wagner’s system to –
Grade 1 – Superficial ulcer.
Grade 2 – Deep ulcer to tendon, bone or joint.
Grade 3 – Ulcer with abscess or osteomyelitis.
Grade 4 – Necrosis of the forefoot.
Grade 5 – Necrosis of the entire foot.
Diabetic foot ulcers are caused by a combination of different causes such as peripheral neuropathy, peripheral vascular disease (PAD), and trauma to the foot. 2
Peripheral sensory neuropathy is one of the main causes of foot ulcers, mainly due to degeneration of the extremity nerve leading to decreased pain and temperature sensation. 3
As a result, sores develop in pressure areas of the foot such as the heel and underside or the tips of the toes. In addition to loss of sensation, some motor deficits and muscle weakness are also caused by nerve damage. This combination of loss of movement and sensation causes changes in the mechanics of the foot that lead to excessive stress on the pressured areas and eventually the formation of ulcers.
Diabetic ulcer management is a multifaceted approach to lifestyle modification, a healthy diet, active control of diabetes, management of comorbidities, and ulcer management. Regular exfoliation followed by the use of different dressing materials such as hydrogel, foam, iodine, ionic silver or dermal peels were in vogue, which kept the wound moist for self-disintegration and provided lipolysis. antibacterial field.
Silver ions are among the most proven antibacterial agents that also have antiseptic and anti-inflammatory properties [including action against antibiotic-resistant bacteria such as Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE)]. 4
Since ancient times, silver coins have been used to disinfect water and liquids stored by the ancient Greeks and Americans. 5
Nanotechnology allows to expand the surface area of silver particles to the nanoscale, thereby increasing the contact time with bacteria or fungi, greatly enhancing the bactericidal and fungicidal effects of silver ions.
This study aimed to evaluate the effectiveness of Nano silver tape compared with Povidone iodine dressing in terms of healing speed, early control of infection when granulation tissue was present, and total hospital stay as well as treatment costs.
MATERIALS AND TEST METHODS – IODINE AND NANOSILVER
Between November 2014 and May 2016, 60 patients with chronic or non-healing diabetic foot or leg ulcers (duration >6 weeks) were admitted to a tertiary care hospital Ours were included in this study. The sample size was selected based on three criteria: study duration, average number of diabetic foot ulcers in our facility over the years and statistical significance. As we have decided on a two-year study period, this sample size is the minimum sample size for statistically significant results during that time.
Data were collected using the Case Recording proforma (CRP) including all detailed histories, clinical findings, routine investigations, diabetes screening, foot X-rays, and studies. Doppler study of arteries and veins and sensitivity to culture of exudate from ulcers.
Computer-generated random numbers using block randomization were used to randomly assign the patients into 2 groups – 30 in the Povidone iodine dressing group and 30 in the Nanosilver dressing group, with the help of numbered envelopes sealed.
Patients with diabetic ulcers associated with peripheral vascular disease and varicose veins (diagnosed by Doppler Study), osteomyelitis, malignancy on steroid therapy and unresponsive to therapy diabetes treatment (Index more than 250 mg%) after 2 weeks of treatment was not included in the study group.
All patients were placed on a strict antidiabetic regimen, covered with antibiotics (according to culture reports), followed by daily hair removal and dressing with the respective dressing materials. The end point of management is complete healing of small ulcers or the appearance of healthy granulomatous tissue that is free of bacteria making the patient suitable for a split skin graft. Research parameters include-
Fast healing.
Infection control and early granulation.
Treatment time and hospital stay are shorter, thus reducing the loss of working days.
Total cost of treatment.
Statistical analysis
In this prospective comparative intervention study, statistical analysis was performed using STATA 11.2 (College Station, TX, USA). Shapiro-Wilk test was used to find normality. Student t-tests were performed to find significant differences between age, length of hospital stay, wound surface area, and total cost, expressed as mean and standard deviation. The Chi-squared test was used to measure the association between sex, the size of the ulcer, the presence of sloughing or granulation tissue and was expressed as frequency or percentage p < 0. 05 was considered to be statistically significant.
TEST RESULTS NANOSILVER
Patients from both groups were thought to be similar in age, sex, and ulcer surface area distribution. Maximum patients were between 41-60 years old, accounting for 70% in the Povidone iodine group and 63.4% in the Nano silver group. Male preference was seen in both groups – 83% (PI) vs 67% (Nano silver). Patients were divided into 4 groups according to ulcer size – A (<5 cm), B (5-7.5 cm), C (7.5-10) and D (> 10 cm). Both dressing groups were statistically similar (p = 0.449) in terms of the total number of patients in each group. (Table 1 and Figure I).
Parameter | Povidone iodine | Nanosilver | Value p | ||
N = 30 | (%) | N = 30 | (%) | ||
Age) 0-20 | 0 | 0% | 0 | 0% | 0,478 |
21-40 | số 8 | 26,70% | 10 | 33,30% | |
41-60 | 21 | 70% | 19 | 63,40% | |
61-80 | 1 | 3,30% | 1 | 3,30% | |
Average ± SD | 49,73 ± 12,48 | 47,47 ± 12,13 | |||
Sex / Male | 25 | 83% | 20 | 67% | 0,135 |
Female | 5 | 17% | 10 | 13% | |
Size of ulcer (cm 2 ) A (<5) | 4 | 13% | 9 | 30% | 0,449 |
B (5-7,5) | 7 | 23% | 5 | 17% | |
C (7,5-10) | 6 | 20% | 6 | 20% | |
D (> 10) | 13 | 43% | 10 | 33% | |
Table 1: Demographic Data of Patient Population | |||||
Value p <0,05 = significantly*
Comparison of desquamation reduction with appearance of granulomatous tissue based on bacterial load
The number of patients with exfoliative ulcers in both groups (at admission and 1 week after dressing change) was not significant (p = 1,000). At the end of week 2 , 26 patients (87%) in the PI group and only 13 patients (43%) in the NS group had skin peeling, which was statistically significant (p = <0.001). Likewise, at the end of the 3rd, 4th, and 3rd week, a faster appearance of healthy granulation tissue was seen in the NS – 26 (87%) and 29 (97%) group patients, respectively, compared with patients in the PI group, showed 9 (30% and 18 (60% respectively), highly statistically significant (p = <0.001). Up to the end of 5 days &6 day weeks, all patients in both groups had no skin shedding and had healthy granulation tissue suitable for split skin grafting. (Figures II & III).
During dressing change, the major organisms encountered in both groups were Haemophilus (6 patients), Klebsiella (9 patients), Proteus (9 patients), Pseudomonas (10 patients), Staphylococcus A adventurer (15 patients). patients) and Streptococcus (11 patients). There was no significant statistical difference during the dressing before (p = 0.844) and after the dressing was also not significant (p = 0.720). But the reduction in bacterial load was achieved more rapidly in NS group patients as described in Table 2.
Parameter | Povidone iodine | Nanosilver | p-Value | ||
N = 30 | % | N = 30 | % | ||
| |||||
Baseline (Day 1) | 29 | 97 | 29 | 97 | 1.000 |
1 week (day th 7 ) | 28 | 93 | 24 | 80 | 0,129 |
2 weeks (day th 14 ) | 26 | 87 | 13 | 43 | <0,001 |
3 weeks (day th21 ) | 21 | 70 | 4 | 13 | <0,001 |
4 weeks (day th 28 ) | 12 | 40 | 1 | 3 | <0,001 |
5 weeks (day th 35 ) | 6 | 20 | 0 | 0 | <0,001 |
6 weeks (day th 42 ) | 0 | 0 | 0 | 0 | <0,001 |
2. Presence of granulomatous tissue | |||||
Baseline (Day 1) | 1 | 3 | 1 | 3 | 1.000 |
1 week (day th 7 ) | 2 | 7 | 6 | 20 | 0,129 |
2 weeks (day th 14 ) | 4 | 13 | 17 | 57 | <0,001 |
3 weeks (day th 21 ) | 9 | 30 | 26 | 87 | <0,001 |
4 weeks (day th 28 ) | 18 | 60 | 29 | 97 | <0,001 |
5 weeks (day th 35 ) | 24 | 80 | 30 | 100 | <0,001 |
6 weeks (day th 42 ) | 30 | 100 | 30 | 100 | <0,001 |
| |||||
Haemophilus | 3 | 10 | 3 | 10 | 0,844 |
Klebsiella | 4 | 13 | 5 | 17 | |
Proteus | 4 | 13 | 5 | 17 | |
Pseudomonas | 6 | 20 | 4 | 13 | |
Staphylococcus | 9 | 30 | 6 | 20 | |
Streptococcus | 4 | 13 | 7 | 23 | |
After getting dressed | 0,720 | ||||
No | 23 | 77 | 25 | 83 | |
Haemophilus | 1 | 3 | 1 | 3 | |
Proteus | 0 | 0 | 1 | 3 | |
Pseudomonas | 4 | 13 | 2 | 6 | |
Staphylococcus | 2 | 6 | 1 | 3 | |
Table 2. Comparison of sloughing versus granulation tissue and the amount of bacteria that cause ulcers | |||||
Value p <0,05 = significantly*
Outcomes of ulcer management
The mean ulcer size at admission & after six weeks in the PI group was 10.13 + – 5.94 and 9.28 + – 4.94, respectively. While in the NS group, it is 8.95 + – 5.81 and 7.00 + – 4.29, respectively. The P value is not statistically significant.
When comparing the results of ulcer healing up to 6 weeks in the PI group, 4 patients (100%) in group A, 2 patients (29%) in group B and 1 patient (17%) in group C showed ulcerative colitis. ulcer healed completely, in contrast This number in NS group was 9 patients (100%) in group A, 2 patients (40%) in group B and 1 patient (17%) in group C. the rest must be skin grafted according to the thickness. Total length of hospital stay was significantly shorter in NS group patients with a mean difference of 6.63 days (p=0.002*) and overall cost was higher in the PI group with a mean difference of 3416 INR and significant p-value of 0.023*. (Table III).
Parameter | Povidone iodine N = 30 | Nanosilver N = 30 | Other meanings | P- Value | ||||
(up to 6 weeks) | Healed | SSG | Flap | |||||
Group A (4) | 4 (100%) | – | – | |||||
B (7) | 2 (29%) | 5 (71%) | – | |||||
C 6) | 1 (17%) | 5 (83%) | – | |||||
D (13) | – | 12 (92%) | 1 (8%) | |||||
Healed | SSG | Flap | ||||||
Group A (9) | 9 (100%) | – | – | |||||
B (5) | 2 (40%) | 3 (60%) | – | |||||
C 6) | 1 (17%) | 5 (83%) | – | |||||
D (9) | – | 8 (89%) | 1 (11%) | |||||
2.Wound surface area (cm 2 ) (mean ± SD) | ||||||||
Baseline (Day 1) | 10,13 ± 5,94 | 8,95 ± 5,81 | 1.18 | 0,390 | ||||
1 week (day th 7 ) | 10 ± 5,91 | 8,75 ± 5,78 | 1,25 | 0,366 | ||||
2 weeks (day th 14 ) | 9,40 ± 6,24 | 8,19 ± 5,37 | 1,21 | 0,443 | ||||
3 weeks (day th 21) | 9,18 ± 5,85 | 9,14 ± 4,61 | 0,982 | 0,943 | ||||
4 weeks (day th 28 ) | 9,02 ± 5,78 | 8,57 ± 4,12 | 0,45 | 0,816 | ||||
5 weeks (day th 35 ) | 9,15 ± 5,13 | 9,10 ± 3,38 | 0,05 | 0,713 | ||||
6 weeks (day th 42 ) | 9,28 ± 4,94 | 7,00 ± 4,29 | 2,28 | 0,395 | ||||
3. Length of hospital stay (days) (average ± SD) | 37,43 ± 6,93 | 30,80 ± 9,00 | 6,63 | 0,002 * | ||||
4.Total cost (INR) (average ± SD) | 14833,33 ± 6156,48 | 11416,67 ± 5635,61 | 3416 | 0,023 * | ||||
Table 3: Outcomes of ulcer management | ||||||||
valuep <0,05 = significantly *
DISCUSS ABOUT NANOSILVER
The main treatment of diabetic foot ulcers (DFU) is surgical excision and the use of different solutions or materials for biodegradation therapy. Selection of an appropriate dressing is a key decision for avid sterilization and removal of necrotic tissue from ulcers in order to correct the microscopic condition of the wound and enhance wound healing in a randomized clinical trial. This prospective course was performed on 60 patients with chronic diabetic foot/leg ulcers. . The study group of 60 patients was divided into two equal and comparable groups of 30 each in the Povidone iodine and Nanosilver groups. Both groups were found to be similar in age, sex, ulcer size, mucus presence, and bacterial load at the time of admission.
Very few series are available comparing ulcer management outcomes between Povidone iodine and Nanosilver dressings, so our series is a learning experience geared towards a comparative analysis. In the study conducted by Kapur V & Marwaha AK, 6 they reported a 90% reduction in slough 18 days (2 nd -3weekly) with Povidone iodine, while in this series the results were not comparable as only 60% reduction in slough was seen by the 4th week of treatment with Povidone iodine. And 90% off after only week th5 . Therefore, the time taken to reduce mucus in this study for patients in the PI group was longer.
Comparing the results of Povidone iodine with Nanosilver, Singh S and Apte A 7 in their study reported that the mean time taken to reduce sludge in the NS group was 11.6 days ( week 2 ) and 18.91 days ( week th 3 ) in the PI group with ap value <0.0001. But in our study, patients in the Nanosilver Group showed 87% reduction in mucus in the 3rd week (p < 0.001) and 97% in the 4th week (p < 0.001).
The longer follow-up time compared to the comparison study may be due to the time spent in active control of diabetes. The appearance of granulomatous tissue in 10% of patients in the PI group and 57% of the patients in the NS group at the end of the 2nd week of dressing change with p-value <0.001.
Comparing the overall reduction in ulcer surface area in both groups, Ramanaiah NV and Saikrishna et al. 8 found this rate to be 94.81% in the NS group compared with 84.69% in the PI group, with statistical significance. But there is no mention of the time taken to reduce this percentage and therefore cannot be compared equally with the present study where we found a change in ulcer size from 8.95+ – 5.81 cm 2 to 7.00 + – 4.29 cm 2 at the end of 6 weeks. in NS patients and from 10.13 + – 5.9 cm 2 to 9.28 + -4.94 cm 2 during the same period in PI patients. Our study highlighted that the type of dressing material did not cause any significant difference in ulcer size reduction.
Singh S and Apte A 7 in their study showed that the mean time to growth failure in the Iodine group was 14.63 days and 9.60 days in the NS group, which was statistically significant (p < 0.001). But in our study, both groups were found to be statistically similar at pre-dressing (p = 0.844) and post-dressing (p = 0.720) in terms of achieving status The state has no organisms to manage further. But a bacterial-free state was achieved in the NS group earlier than in the PI group, thus significantly reducing the length of hospital stay.
In one study, the hospital stay was significantly shorter in the NS group (30.0 + – 9.09 days) than in the PI group (37.43 + – 6.93 days) and was also statistically significant ( P < 0.002). Our results are comparable with those of Ramanaiah et al. 8 , who also found a statistically significant (P < 0.001) shorter length of stay in their study in NS patients. .
Due to the shorter length of stay, patients in the NS group spent approximately 11416.67 + – 5635.61 (INR) in our study, while the other group spent 14833.33 + – 6165.48 ( INR), with a mean difference of 3414 INR, was statistically significant (p < 0.023). No comparative studies were found on total costs incurred in both groups but in studying Stephens R, Silverstein P et al, 9 a 33% reduction in labor and supply costs was observed. when silver was used compared with other standard treatments.
CONCLUSION
Diabetic foot ulcers are not only a serious problem for patients, but also a major health care concern due to the loss of man-hours and the high cost of treatment. Povidone iodine has been used to bandage sores for a long time with good results as demonstrated in data studies. But Nanosilver is a relatively new compound and has not been as widely used as Povidone iodine. It showed some promising results in this study, both in terms of length of hospital stay and overall lower treatment costs. However, because not many studies have been done with this compound, it is limited compared to other studies. Therefore, there is a need to do more testing and confirm the effectiveness of Nanosilver to achieve faster and better healing in patients with diabetic foot ulcers.
Therefore, we conclude that NS can be considered as a better alternative to Povidone iodine in the rapid and safe management of all patients with diabetic foot/leg ulcers.
Reference:
Abdur Rahaman1, Akshatha Manjunath2, Aparajita Mookherjee Bhattacharya3
1Postgraduate Student, Department of General Surgery, Vydehi Institute of Medical Sciences and Research Centre, Bangalore.
2Assistant Professor, Department of General Surgery, Vydehi Institute of Medical Sciences and Research Centre, Bangalore.
3Professor, Department of General Surgery, Vydehi Institute of Medical Sciences and Research Centre, Bangalore.