 |
       |
|
|
CLINICAL TRIAL OF A HERBAL ANTISEPTIC CREAM IN THE TREATMENT OF MINOR INJURIES
SV INDRA KUMAR
Professor and HOD, Department of Dermatology, Bangalore Medical College, Bangalore, India.
An open clinical trial was conducted in patients with minor lacerated wounds sustained by mild trauma injuries. The lacerated wounds were treated with a herbal antiseptic cream for which the clinical efficacy was studied. The cream was applied twice daily for 15 days with follow-up on every 5th day. The clinical efficacy included parameters such as the size and number of lacerated wounds, discharge, pain and formation of granulation tissue. Among 50 cases studied, 45 completed the study, 3 cases did not report for follow-up and 2 cases discontinued treatment as they developed swelling of inguinal lymph nodes accompanied with fever. In 18 cases, there was healing of lacerated wounds occurred within 5 days of treatment (complete debridement of necrotic tissue with formation of granulation tissue), 20 cases showed healing within 6-10 days while in 5 cases, healing was observed within 11-15 days. Two cases did not respond to treatment. There were no untoward adverse effects in any of the patients.
INTRODUCTION
Surgeons, dermatologists and general practitioners have been concerned with wound healing since the time of the Egyptians. In every healing process, regardless of the tissue type or cause of injury, there is an occurrence of events in the same order. Tissue injury or frank necrosis allows wounds to heal by forming scar tissue. Some animals such as the stone crab and the salamander can regenerate amputated parts but mammals do not have the ability to regenerate organs and body parts with the exception of bone and the liver. After the foetal stage, all healing occurs with an overlapping series of orchestrated events to limit the damage and restore the function and integrity of the structure. All tissues undergo the same series of events and are divided into specific stages. However, these phases overlap both in time and activity. The extent of damage, healing time and formation of the scar are all affected by several extrinsic factors. The extent of tissue lost or damaged, the amount of foreign material or bacterial inoculation and the duration of exposure to toxic factors affects recovery time. Blood supply to the affected area also determines the healing process; for example, blood supply to the lower extremity is rather poor while there is better blood supply to the face and hands. It has been observed that the healing process is slower in older persons.
Clinical evidence has shown that topical antiseptics or antibiotics are both safe and effective in treating minor cuts and burns. However, recent investigations have clarified the efficacy of certain herbal topical formulations used in the treatment of these conditions. A clinical trial was conducted on a herbal Antiseptic Cream intended solely for topical application with claims of having undergone extensive clinical evaluation for treating minor cuts and burns. In order to understand the uses for this topical antiseptic preparation, it is essential to know the activity of the individual herbs present in it. Aloe vera (Kumari) acts as an antibacterial and astringent. It accelerates the healing of injured surfaces. Aloe appears to expedite wound contraction and neutralises the wound retardant effect. This effect may be due to increased collagen activity, which is enhanced by a lectin, consequently improving the collagen matrix and enhancing the breaking strength.[1] An amorphous hydrogel dressing derived from the aloe plant is approved by the Food and Drug Administration for the management of pressure ulcers.[2] The fresh juice of the leaves has a cooling effect and has been found effective in treating burns, dermatitis and other disorders of the skin. Rubia cordifolia (Manjistha) is credited with astringent, antibacterial, antiallergic and antiseptic properties. It is useful in skin infections, wound, inflammation and other skin disorders. It also has antibacterial and antiallergic action.[3] Vitex negundo (Nirgundi) oil extract has good anti-inflammatory and anti-infective properties and is useful in treating superficial bruises, injuries, sores and skin infections. Vitex negundo has shown significant antibacterial activity against tested bacteria.[4] Prunus amygdalus (Vatadha) is known to exert a cooling action on inflamed wounds.[5] Tankana (Borax) is an effective astringent and antiseptic useful in treating superficial infections, prickly heat, acne and ulcers. Studies have indicated that Yashada bhasma (Zinc calx) is effective in the treatment of a number of skin disorders, accelerates wound healing and possesses antiseptic and astringent properties. Clinical trials have demonstrated that saline dressings impregnated with zinc are associated with faster healing and epithelialization of wound. The use of topical antibiotics impregnated with zinc resulted in significantly lower infection rates.[6]
MATERIAL AND METHODS
As open clinical trial was conducted in 50 patients (33 males and 17 females) in the age group of 20-50 years whose informed consent was obtained at the commencement of the study. These patients had minor lacerated wounds in different parts of the body sustained from mild trauma (Table 1). They were dispensed Antiseptic Cream and instructed to apply it twice daily over the affected area. Identification numbers were given to all patients with standard instructions to inspect, clean, and redress their wounds twice daily. They were demonstrated the technique of wound cleaning with a non-detergent soap before applying the cream and advised to keep away from contamination and dust. They were required to report for follow-up every 5th day for 15 days till the lesions healed. Initially and at each follow up, proper debridement of the wounds was done and they were evaluated for clinical infection. The patients were assessed on the number of wounds that had healed, intensity of pain and discharge from the wounds. The overall clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: Severe : 3, Moderate : 2, Mild : 1, Disappearance of the symptoms : 0. No other topical or systematic antibiotics were permitted during the trial.
TABLE 1
Presence of lacerated wounds in different parts of the body (n=50)No. of patients Site of wounds 03 Head/Neck 34 Limbs 08 Trunk 05 Axilla/groin
RESULTS
Out of the 50 cases enrolled in the study, 45 patients completed the trial period, 3 patients were lost for follow up and 2 patients who complained of fever and enlargement of superficial inguinal lymph nodes had to be withdrawn from the trial. During the first follow up after 5 days, it was observed that 18 (45%) cases had total relief of symptoms and their wounds had completely healed. On the 10th day, another 20 (total 84.44%) patients showed wound healing. By the 15th day, 43 out of 45 patients (total 95%) who were followed up showed improvement in healing of wounds and formation of good granulation tissue (Table 2). However, 2 cases had to be dispensed systemic antibiotics. The statistical analysis showed significant improvement (p < 0.0001) (Table 3).
TABLE 2
Overall therapeutic response to treatment with Antiseptic CreamSymptoms 5th day 10th day 15th day Healed completely 18 38 43 Improved 20 5 2 Unchanged 7 2 2
TABLE 3
Statistical analysis of wound healingDuration No. of wounds Pain Discharge Baseline 2.80 ± 0.24 1.90 ± 0.17 2.30 ± 0.20 Day 5 1.670 ± 0.14 1.40 ± 0.15 2.10 ± 0.41 Day 10 1.30 ± 0.14 1.10 ± 0.09 1.0 ± 0.35 Day 15 0.30 ± 0.20* 0.20 ± 0.13* 0.30 ± 0.20* *p < 0.0001
DISCUSSION
An open wound fills with granulation tissue and contraction enhances wound closure by pulling the surrounding uninjured tissue over the affected area. A fibrin clot will seal the wound permanently by epithelialisation. Tensile strength is achieved by deposition of collagen and other matrix proteins. During the maturation phase, the wound further contracts as collagen cross-linking occurs. Knowledge of the dynamics of wound healing allows the physician to appropriately treat the patient to achieve closure as rapidly as possible with little scarring and loss of function. The reduction in inflammation, rapid closure of the wound, elimination of foreign material and bacteria allow the wound to progress to synthesise scar formation and achieve structural integrity.
Several antibacterial and anti-infective preparations are available in the market. However, many side effects have been reported in various studies conducted with these preparations. Systemic anaphylaxis following topical application of Bacitracin have been reported but all patients had multiple previous exposures and prior local reactions of pruritus, urticaria, or possible allergic contact dermatitis.[7] Contact allergy is connected to uses of neomycin. Patch tests carried out have shown its prevalence ranging from 1.7% to 19%, with most studies reporting a frequency of about 3.5% to 6%.[8] For example, in 192 patients with stasis eczema and leg ulcers, 34% had positive skin reaction to neomycin.[9] Investigations on patch tests carried out in clinics are, however, unrepresentative of the general population. Two separate studies showed neomycin contact allergy in 1.1% and 0.09%.[10,11] Most of the patients with positive skin tests (83%) reported having used neomycin for at least one week on an inflammatory dermatosis. Nearly all patients with positive tests subsequently applied neomycin ointment to normal skin without developing severe dermatitis; however, isolated pruritic papules appeared. Some patients with positive skin tests to neomycin also react to bacitracin. As the two agents are not chemically related, these responses apparently represent independent sensitisation rather than cross-reactions.[12] Patients with neomycin allergy, however, may have cross sensitivity to other aminoglycosides such as gentamicin.
The use of topical antibiotics increases the risk of organisms developing resistance to the agents employed. Transmission of genes including plasmids governing antimicrobial resistance occurs on the human skin.[13] For a medication like gentamicin, which has important systemic uses, such resistance may markedly reduce its efficacy in treating serious infections.
Other agents like neomycin and bacitracin have little systemic use and antibiotic resistance can render them ineffective for topical therapy. Resistance is often related to extensive utilisation of an agent, especially in confined settings such as hospitals, where its use is curtailed or discontinued.[14] High-level, plasmid-mediated resistance, rapidly lost on subculture, has occurred in dermatology ward patients with both S. aureus and coagulase-negative (staphylococci. Several of them have received long-term mupirocin therapy.[15] A lower-level, more stable resistance may also develop with the use of mupirocin and it has occurred within three weeks in one patient.[16-18] This and the previous studies indicate that topical therapy, even with those antibiotics that have no systemic indications, should not be protracted and should be prudently restricted in confined settings, such as hospital wards. Widespread indiscriminate use may render the agents ineffective.
In this trial, it was observed that treatment with Antiseptic Cream produced "cleaner and healthier granulation tissue". By more effectively eradicating bacteria, this topical Antiseptic Cream may produce a faster rate of healing in cutaneous infections than a placebo or no treatment. When used to prevent suppuration in wounds that are sterile or colonised with bacteria, but not clinically infected, these agents have unpredictable effects on wound healing. This herbal Antiseptic Cream can be an alternative remedy for treating minor cuts, burns and lacerated wounds. Its antibacterial effect is probably due to the synergistic action of the different herbs in the formulation.
CONCLUSION
From this study, it can be concluded that Antiseptic Cream used in the treatment of minor lacerated wounds accelerated the rate of healing, reduced pus and odour from wounds, removed necrosis and inflammation, reduced wound size and prevented hypertrophic scarring. These findings suggest that Antiseptic Cream is an excellent additive to the total therapeutic management of minor lacerated wounds.
REFERENCES
1Heggers JP, Kucukcelebi A, Listengarten D, et al. Beneficial effect of Aloe on wound healing in an excisional wound model. J Altern Complement Med 1996; 2 (2) : 271-7.
2Thomas DR, Goode PS, LaMaster K, et al. Acemannan hydrogel dressing saline dressing for pressure ulcers : A randomised, controlled trial. Advanced Wound Care 1998; 11 (6) : 273-6.
3.Warrier PK, Nambiar VPK, Raman Kutty. Indian Medicinal Plants, 1st Edition, Orient Longman Publication, Hyderabad, India. 1996; 5 : 17.
4.Perumal Samy R, Ignacimuthu S, Sen A. Screening of 34 Indian medicinal plants for antibacterial properties. Journal of Ethnopharmacology 1998; 62 (2) : 173-82.
5.Nadkarni KM, Indian Materia Medica, 3rd edition. Bombay Popular Prakashan, Bombay, India. 1996; 2 : 103-7.
6.Dire DJ, Coppola M, Dwyer DA, et al. Prospective evaluation of topical antibiotics for preventing infections in uncomplicated soft-tissue wounds repaired in the ED. Academic Emergency Medicine 1995; 2 (1) : 4-10.
7.Schechter JF, Wilkinson RD, DelCarpio J. Anaphylaxis following the use of bacitracin ointment : Report of a case and review of the literature. Archives of Dermatology 1984; 120 : 909-11.
8.MacDonald RM, Beck M, Neomycin : A review with particular reference to dermatologic usage. Clinical and Experimental Dermatology 1983; 8 : 249-58.
9.Fraki JE, Peltonen L, Hopsu-Havu VK. Allergy to various components of topical preparation in stasis dermatitis and leg ulcer. Contat Dermatitis 1979; 5 : 97-100.
10.Prystowsky DS, Allen AM, Smith RW, et al. Allergic contact hypersensitivity to nickel, neomycin, ethylene diamine and benzocaine. Archives of Dermatology 1979; 115 : 959-62.
11.Leyden JJ, Kligman AM. Contact dermatitis to neomycin sulfate. JAMA 1979; 242 : 1276-8.
12.Katz BE, Fisher AA. Bacitracin : A unique topical antibiotic sensitiser. Journal of the American Academy of Dermatology 1984; 23 : 547-9.
13.Noble WC. Choice of topical antibiotic : A microbiological view point. Clinical and Experimental Dermatology 1981; 6 ; 503-7.
14.Alder VG, Gillespie WA. Influence of neomycin sprays on the spread of resistant staphylococci. Lancet 1967; 2 : 1062-3.
15.Rahman M, Noble WC, Cookson B. Mupirocin-resistant. Staphylococcus aureus. Lancet 1987; 2 : 387.
16.Baird D, Coia J. Mupirocin-resistant. Staphylococcus aureus. Lancet 1987; 2 : 387-8.
17.Kavi J, Andrews JM, Wise R. Mupirocin-resistant Staphylococcus aureus. Lancet 1987; 2 : 1472.
18.Smith MD, Sanghrajka M, Lock S. Mupirocin-resistant Staphylococcus aureus. Lancet 1987; 2 : 1472-3.
 |