|Year : 2020 | Volume
| Issue : 3 | Page : 240-243
Comparison of octenidine wound gel versus povidone-iodine dressing in healing of chronic diabetic foot ulcers: A randomized controlled trial for period of 1 year
Sreenivasa Reddy Guddety, Basavaraj M Kajagar
Department of General Surgery, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India
|Date of Submission||09-Jan-2020|
|Date of Acceptance||20-May-2020|
|Date of Web Publication||05-Oct-2020|
Dr. Basavaraj M Kajagar
Department of General Surgery, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi-10, Karnataka
Source of Support: None, Conflict of Interest: None
Context: Octenidine is an antiseptic known for the past 20 years. Very few clinical studies have been done in evaluating the advantages of octenidine. Specific characters of no anti microbial resistance, good host tissue tolerability and very few clinical studies made us to conduct this study.
Aims: To compare octenidine wound gel dressing versus povidone-iodine (PVI) dressing in healing of chronic diabetic foot ulcers (DFUs) in terms of mean percentage reduction in the ulcer area.
Settings and Design: A randomized controlled study was conducted at a tertiary care hospital in North Karnataka between January 2018 and December 2018.
Subjects and Methods: Eighty cases of chronic DFU were selected and randomized (sequentially numbered, opaque-sealed envelopes technique) into two groups – Group A: octenidine dressing done and Group B: PVI dressing done for 14 days. The wound healing was calculated as the mean percentage reduction in the ulcer area. The wound healing was then compared between two groups.
Statistical Analysis Used: Student's unpaired t-test and Chi-square test were used for analysis.
Results: Ulcer healing was early in Group A compared to Group B; the mean percentage reduction in the ulcer area was 25.51 ± 9.26 and 14.48 ± 6.54 sq.cm in Group A and Group B, respectively (P < 0.001).
Conclusions: Octenidine wound gel has shown good progress of ulcer healing in terms of ulcer area reduction compared to PVI dressing.
Keywords: Diabetic foot ulcer, octenidine, povidone-iodine
|How to cite this article:|
Guddety SR, Kajagar BM. Comparison of octenidine wound gel versus povidone-iodine dressing in healing of chronic diabetic foot ulcers: A randomized controlled trial for period of 1 year. Indian J Health Sci Biomed Res 2020;13:240-3
|How to cite this URL:|
Guddety SR, Kajagar BM. Comparison of octenidine wound gel versus povidone-iodine dressing in healing of chronic diabetic foot ulcers: A randomized controlled trial for period of 1 year. Indian J Health Sci Biomed Res [serial online] 2020 [cited 2020 Dec 2];13:240-3. Available from: https://www.ijournalhs.org/text.asp?2020/13/3/240/297191
| Introduction|| |
Diabetic foot ulcers (DFUs) are the common complications of diabetes., Foot illness includes almost 6% of individuals with diabetes.,,
Management of infected DFU includes ulcer debridement, application of topical antimicrobial/antiseptic agents, and systemic antibiotics, if indicated.
Octenidine, an antiseptic,, interacts with organism cell wall and breaks it. It has high bacteriological index and no microbial resistance. Hydrogel-based preparation of octenidine has additional properties of hydrogel., All these characters and very few clinical studies made us to compare healing of DFU, between octenidine and routinely used povidone-iodine (PVI) dressings in terms of mean percentage ulcer area reduction.
| Subjects and Methods|| |
This prospective, open-label, parallel randomized control trial was conducted at a tertiary care hospital in North Karnataka for 12 months. All patients provided informed consent before enrolment into the study. Patients admitted to the surgery ward with Type 2 diabetes mellitus aged between 35 and 75 years, Wagner Grade 1 foot ulcers with duration more than 4 weeks, and able to give informed consent were included in the study. Patients suffering from osteomyelitis, collagen/ischemia/peripheral vascular diseases, and malignancy and having immune compromised status were the excluded. A total of 80 patients were included for the study. The sample size was obtained after a pilot study based on the formula to calculate the sample size for testing a hypothesis (, including average of standard deviation between two groups (S = 0.503), effect size (mean difference – d = 0.4241), Zα=1.96 at 5% error, and Zβ=21.037 at 85% power. They were randomized into two groups with 1:1 ratio (n = 40) by sequentially numbered, opaque-sealed envelopes technique. Group A received octenidine wound gel dressing Octenidine (OCT) and Group B received PVI dressing. Ethical clearance was obtained from the institutional ethics committee Ref.no. MDC/DOME/13: dt : 22/11/2017 was obtained.
Surgical debridement was performed before the treatment in both groups. Empirical antibiotics, ceftriaxone/cefotaxime and metronidazole, were started and specific antibiotics after culture report were obtained. Blood glucose levels were controlled by oral hypoglycemic agents and insulin as advised by physician. In both the groups, wounds were cleaned with normal saline and then dressing was done as follows:
Group A patients octenidine wound gel (zotobac gel) has been applied and amount to be applied has been calculated as one fingertip which is approximately 0.5 gm for 2% of body surface area (I.I.E., Sidcul, Haridwar, Uttarakhand).12] A normal saline-soaked gauze has been placed over the surface and dressing was applied.
Group B patients' wounds were dressed with gauze soaked in PVI 10% w/v solution.
The frequency of dressing in both groups was once a day. Patients were followed up for 14 days from theday of recruitment.
Wounds were assessed after each dressing by observing various parameters such as size, surrounding skin, and ulcer area on the days 0, 7, and 14. The outcome was the mean percentage reduction in the ulcer area between two groups after 14 days of treatment.
The dimensions of ulcer were measured using a mobile software “imito measure;” a digital image of an ulcer was taken using an android phone with application installed and processed. The software then calculated the measurements of ulcer area automatically.
Analysis was done using independent t-test and Chi-square test. P < 0.05 considered statistically significant. All statistical analysis was carried out using IBM SPSS version 22. (IBM, Arkam, New York, United States of America).
| Results|| |
A total of 80 patients were randomized to treatment by OCT (n = 40) or PVI (n = 40) [Flow Chart-1]. All the demographic characteristics [Table 1] such as age, sex, socio economic status, and duration of diabetes have shown no significant variation in distribution, all P > 0.05. About 48 out of 80 patients (60%) were above 55 years of age, 55 out of 80 patients (68.75%) were males, and 50 out of 80 patients (62.5%) belonged to low economic status.
[Table 2] shows the distribution of patients with known risk factors for wound healing such as neuropathy, hypertension, and uncontrolled diabetes had no significant variation, all P values were above 0.05.
Mean initial ulcer area had no statistical significance between two groups (P = 0.730) whereas mean final ulcer area was statistically significant between two groups (P = 0.041). Mean reduction in the ulcer area (D0–D14) and mean percentage reduction in the ulcer area was also statistically significant between two groups (P < 0.001). With 95% confidence interval, percentage reduction in the ulcer in Group A was between 28.38 and 22.64 sq.cm and in Group B was between 16.50 and 12.46 sq.cm.
| Discussion|| |
Diabetes is considered the new emerging epidemic of the world. Neuropathy and peripheral vascular disease are the complications of diabetes that predispose to foot ulceration in diabetics ,, Infection is commonly seen in DFU. As per the study by Prompers et al., around 58% of the individuals presenting to the podiatry clinic have an infection at their initial presentation, and this percentage may go up to 82% of the DFU patients admitted to hospital.
Besides adequate wound debridement and antibiotic therapy, dressing plays an important role in the healing of DFU. Usage of topical antimicrobial or topical antiseptic agents is still considered as an option in infected ulcers.
Most of the study population was above 55 years of age and males. In our study, it was noted that 62.5% of population was belonging to low economic status; this might be because of bare foot walking and poor wound care due to economic limitations; we suggest that education about importance of foot wear and need for regular follow-up and assessment of foot will help reduce the incidence among this economic group.
Confounding factors such as hypertension, neuropathy, and uncontrolled diabetes were eliminated by distributing equally among two groups.
Octenidine, a new antiseptic with a unique chemical structure and wide antimicrobial activity, is now available as an antiseptic for chronic infected ulcers. Recent studies on octenidine suggest that it is less cytotoxic, tissue compatible with good antimicrobial activity.,
PVI is a complex of povidone, which is a synthetic polymer, and iodine is the antimicrobial. Povidone is the carrier for iodine in this preparation. Disadvantage of iodine preparation is its systemic absorption and toxicity; it is contraindicated in thyroid disease, very low birth weight, known toxicity, and in patients receiving radio-iodine therapy.,
The mean reduction in area in Group A (OCT) was 6.92 ± 3.38 sq.cmand in Group B (PVI) was 3.57 ± 1.54 sq.cm. The difference in reduction in the area between the two groups was significant (P < 0.001). The mean percentage reduction in area in Group A was 25.51 ± 9.26 sq. cm and in Group B was 14.48 ± 6.54 sq.cm. The difference in percentage reduction in the area between the two groups was significant (P < 0.001). The difference in percentage reduction in the area between the two groups was significant (P<0.001) [Table 3]. These findings suggest that dressing and topical application of octenidine wound gel favors ulcer healing compared to dressing and topical application of PVI. These findings were consistent with the studies conducted earlier.,,,,,,,
|Table 3: Comparison of mean of parameters of ulcer area in sq.cm between the groups|
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The earlier wound healing process in this study can be explained by the effective antimicrobial and autolytic property of octenidine wound gel. The autolytic activity of this octenidine wound gel is due to the gel-based form of antiseptic. This gel rehydrates the nonviable tissue and plays a role in the process of natural autolysis.
| Conclusions|| |
Based on the results from this study, we conclude that, when octenidine wound gel is added to the treatment regimen of the patients with DFU, it has shown good progress of ulcer healing in terms of ulcer area reduction compared to PVI dressing.
We thankall participants in the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
American Diabetes Association. 2. Classification and diagnosis of diabetes. Diabetes Care 2015;38 (Suppl 1):S8-16.
Ibrahim AM. Diabetic foot ulcer: Synopsis of the epidemiology and pathophysiology. Int J Diabetes Endocrinol 2018;3:23.
Papatheodorou K, Banach M, Bekiari E, Rizzo M, Edmonds M. Complications of diabetes 2017. J Diabetes Res 2018;2018:3086167.
Pickwell K, Siersma V, Kars M, Apelqvist J, Bakker K, Edmonds M, et al
. Predictors of lower-extremity amputation in patients with an infected diabetic foot ulcer. Diabetes Care 2015;38:852-7.
Aumiller WD, Dollahite HA. Pathogenesis and management of diabetic foot ulcers. JAAPA 2015;28:28-34.
Mishra SC, Chhatbar KC, Kashikar A, Mehndiratta A. Diabetic foot. BMJ 2017;359:j5064.
Dumville JC, Lipsky BA, Hoey C, Cruciani M, Fiscon M, Xia J. Topical antimicrobial agents for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev 2017;6:CD011038.
Hübner NO, Siebert J, Kramer A. Octenidine dihydrochloride, a modern antiseptic for skin, mucous membranes and wounds. Skin Pharmacol Physiol 2010;23:244-58.
Monnet DL, Brandt CT, Kaltoft MS, Bagger-Skjøt L, Sørensen TL, Nielsen HU, et al
. High prevalence of macrolide resistance: Not in every country! Comment on: Halpern et al
. J Antimicrob Chemother 2005; 55: 748-57. J Antimicrob Chemother 2005;56:433-4.
Greener M. Octenidine: antimicrobial activity and clinical efficacy. Wounds UK. 2011;7:74-8.
Braun M, McGrath A, Downie F. octenilin® range made easy Wounds UK.2013;9. Available from: www.wounds-uk.com/made-ea. [Last accessed on 6 june 2020]
Long CC, Finlay AY. The finger-tip unit – A new practical measure. Clin Exp Dermatol 1991;16:444-7.
Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, et al
. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia 2007;50:18-25.
Malinovskií NN, Reshetnikov EA, Rubashnaia IE, Mal'nikova GN, Mitiukov AP. Antiseptics on the base of Octenidine Hydrochloride. Khirurgiia (Mosk). 1997;:8-10.
Müller G, Langer J, Siebert J, Kramer A. Residual antimicrobial effect of chlorhexidine digluconate and octenidine dihydrochloride on reconstructed human epidermis. Skin Pharmacol Physiol 2014;27:1-8.
Vanscheidt W, Harding K, Téot L, Siebert J. Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic – A randomized, double-blind controlled study. Int Wound J 2012;9:316-23.
Koburger T, Hübner NO, Braun M, Siebert J, Kramer A. Standardized comparison of antiseptic efficacy of triclosan, PVP-iodine, octenidine dihydrochloride, polyhexanide and chlorhexidine digluconate. J Antimicrob Chemother 2010;65:1712-9.
Hämmerle G, Strohal R. Efficacy and cost-effectiveness of octenidine wound gel in the treatment of chronic venous leg ulcers in comparison to modern wound dressings. Int Wound J 2016;13:182-8.
Eisenbeiβ W, Siemers F, Amtsberg G, Hinz P, Hartmann B, Kohlmann T, et al
. Prospective, double-blinded, randomised controlled trial assessing the effect of an Octenidine-based hydrogel on bacterial colonisation and epithelialization of skin graft wounds in burn patients. Int J Burns Trauma 2012;2:71-9.
Korzon-Burakowska A, Przezdziak M, Orlowska-Kunikowska E, Sipponen A, Jokinen JJ. Healing of Neuropathic Diabetic Foot Ulcers of PEDIS Grade 1-2 at Home Care with Topical Antiseptics: An Observational Follow-Up Investigation. J Clin Exp Dermatol Res. 2017;8:2.
Assadian O, Hämmerle G, Lahnsteiner E, Simon D, Antunes JN, von Hallern B, et al
. Facilitating wound bed preparation: Properties and clinical efficacy of octenidine and octenidine-based products in modern wound management. J Wound Care 2016;25 (Suppl 3):S1-27.
[Table 1], [Table 2], [Table 3]