Étude clinique sur l'efficacité de MelOp G et E (1986)
Medical University Novi Sad
Institute for Surgery
Clinic for plastic surgery and burns
Research Results of the effects of MelOp Balsam G + E on fresh burns and its scars
The balsams which are produced in "Menta" from Padej, are subject of our research, i.e. whether and to what extent they heal burns and also scars, regardless they are consequence of burns or they have some other aetiology, like injuries, surgical cut or scars upon vaccination, etc.
Chemical analysis of MelOp balsam had been performed in 1972, in the Institution for health protection of Republic of Serbia, Department for sanitary chemistry and biochemistry, in Belgrade under no. PO 687 and laboratory no. 120. At that time the balsam that was analysed belonged to Jovan Šaljić, from Ivangrad, and today it has been the same balsam only it is has been produced in Padej. Analysis result: Dense balsam (G), which has been used for burns treatment is a solid, yellow ointment, ph value 5,0. Balsam sample (E) - for scars treatment - is light yellow emulsion, ph value of mixture with water is 5,4. The samples do not include arsenic, mercury, bismuth and lead. The samples of the balsams G and E for burns and scars treatment do not contain metals that could harmfully effect patient's health. The balsam samples are regularly sent for sterility inspection, which ensures safe research of the respective balsams on people.
Balsam G (dense) is applied on fresh burns according to the principle for the burns treatment with a bandage i.e. closed method.
After cleaning of a burn itself and its surrounding area with antiseptic, the surface should be washed with physiologic solution, then dried and the balsam should be applied on burnt surface without removing of blisters, but the blisters should be opened and dried from accumulated electrolytic and plasmatic liquid. The applied ointment layer should be 2 - 3 mm thick and should be covered with a few layers of gauze. Then, a bandage should be placed, but without compression, due to possible swelling and circulation jeopardising of that region.
Balsam appliance gives fast analgesic effect and eliminates pain from burns. We consider this effect as very significant one because the pain is one of the factors that negatively influence on overall patient's condition. Also, this treatment is simple and time is not wasted by removing of dead epidermis and therefore we are shortening the whole procedure. Also, we are not causing the additional patient's trauma since he/she is very sensitive to any additional pain. The destroyed epidermis is easily and painlessly removed in 2 - 3 days as a dry crust, when the patient's condition has been improved. It is important to eliminate plasma from blister during treatment, as this could cause infection.
This shortened procedure could be applied in cases in which is present indication for delayed primary treatment.
Regarding surface (skin-deep) burns both epidermal and dermal, renewing of epithelium is quick, in 7 - 12 days. This period is completely painless.
As for deep burns, on small surfaces, where the benefit of balsam G was most frequently tested, we acquired faster demarcation of necrosis, with epithelisation from the rims and from preserved epithelium cells of sweat and sebaceous glands drain.
Regarding extensive burns both dermal or sub dermal, we perform usual early tangential necrotomy with placing of transplants, but on the remaining areas where we could not succeed to cover with transplants we applied balsam G.
In that manner we quickly got clean surface on the areas that were not operated and that surface was adequate for later secondary plastic surgery. In considerable number of cases on those regions epithelisation would occur. This epithelium is less worth as it has developed from surviving epithelial cells of glands drain, but it has played an important role in wound healing process. Later on if it has low resistance on injuries skin transplants can replace it. We have concluded that MelOp G increases biological potential of treated region, accelerates epithelisation from remaining healthy cells and simultaneously inhibits proliferation of connective tissue. Healing is ended with minimum number of scars. Immediately after wounds healing the treatment with MelOp E should commence as a preventive scar balsam.
Our experiences with Balsam E are considerably larger because we have had more appropriate occasions for its research in ambulatory-polyclinic practice and we invited patients for one-month check-up examinations. The observation was effected for over 50 patients with scars, which originated mostly from the past and were not properly treated, including patients who were inclined to scars forming.
The balsam appliance is simple and it is also important that there is no danger of infection or patient's unprofessional application. The adequate application procedure is shown to a patient and he continues the therapy at home accordingly. The scar should be washed with a glycerine soap and lukewarm water. The emulsion should be applied on skin for several times a day and bandage should be tightened overnight. We apply elastic bandages against scars, so we revised the method by firm bandages appliance over the balsam.
As for fresh scars, we had surprisingly good results, while the old keloids were difficult for healing and also the time of 6 months is too short to show some significant progress for treatment of thick keloids.
In order to achieve result with a patient who has very conspicuous keloids on shoulders we combined the balsam with surgical procedure; i.e. we removed keloids by surgery, we did not sew up the transplant but it was laid and it cicatrised very good on wounded surface. We left out sewing up, because each piercing of needle could be stimulus for keloids recidivism. Immediately after transplant receiving in order to avoid recidivism we applied MelOp E, proving that it could participate successfully within combinations with surgical methods. Finally, this is its most important indication i.e. to prevent forming of cicatricial tissue, to inhibit production of connective tissue, and compressive bandage has its sole role to make the jeopardised region anaemic, which reduces blood circulation and fibroblast flowing. The combination of MelOp E and compressive bandage upon surgery resulted with success. Therefore, the conclusion is that in future we can perform excision and plastic surgery freely and in continuation we can give to MelOp E the opportunity to effect preventively in order to avoid keloids recidivism!
Research of MelOp G and E balsams began in November 1986. and it had been lasted for 6 months. We have introduced a detailed check-up examination for each patient treated with the balsam. All observations are included in a special file that represents check-ups and results documentation. A number of patients were healed in a short period, but others were healed slowly or balsam appliance was irregular or improper. The instructions for use were given; it was suggested combination of therapies, applied balsam therapy and compression with elastic bandage.
60 patients were treated in total, 10 patients with recent burns and 50 with scars. There were not only sequelae that followed the burns but also scars of different origin.
Hereby, with this project report we are presenting our positive opinion for balsams MelOp G and E and we will proceed with the research and keeping records. Until present we have had ideas for the treatment improvement, especially cheloids and also combinations of surgery and balsam appliance for treatment of burns on remaining surfaces that could not be immediately operated.
Conclusion
Although a burn is surgical problem and it is solved, especially in deep and extensive cases, by surgery i.e. by primary tangential necrotomy, we also have MelOp G and E that could be of significant benefit. These balsams are useful for surface burns and they quickly lead to painless epithelisation. As for deep dermal burns they show inhibition towards connective tissue and at the same time they are effective in increasing of healthy cells biological potential, which contributes to epithelisation and prevents forming of deep scars. MelOp E gives excellent results in treatment of fresh cases and in keloidal cases also has positive effects combined with surgery treatment in compressive bandages. The balsam facilitates healing of burns and scars prevention, i.e. preserve the functions of important organs and vital human functions. Besides the above mentioned characteristics patients are emphasising soothing analgesic effect of the balsams.
Dr. Obradovic Tomasev Milena
Prof. Dr. Branislav Bogdanov
Dr. Pisarev Soc Milena
Etude clinique sur l'efficacité de MelOp G (1987)
The preparation MelOp G balsam, "Menta", Padej, has been analysed on the Clinic for dermatological and venereal diseases of the Medical University, Novi Sad, from January until April 1987.
The analysis purpose was therapeutic effectiveness evaluation of MelOp G balsam in ulcer healing with dermatological patients. Taking into consideration large number of cases and specific therapeutic problem, it was anticipated to include in the observation primarily patients with ulcers of veined origin while other patients with ulcerous changes of different genesis should have been analysed in lesser degree.
Analysis Modality and Criteria for Results Assessment
It was foreseen to include in observation about 40 patients with clearly emphasised changes of the ulcer forms, with previously suppressed infection, and also they should be in phase of granulation. MelOp G was applied on ulcers two times a day in a thin layer over wound bottom, after prior washing with 3% hydrogen peroxide solution. In the frame of general therapy, the medicines that could have affected blood stream (vasodilators, etc.) including appliance of other medications for local use on surrounding skin were avoided. This research did not include the patients with illnesses that could seriously affect healing of wounds (decompensated cardiovascular patients, diabetics).
Observation of each patient, i.e. treatment period with MelOp G lasted for one month. During that period 3 compulsory examinations were performed, in the beginning, in the middle and in the end of observation, with objective result assessment and data registration into special file made for each patient.
The most important observation method was objective measurement of ulcer surface on each check-up examination, i.e. comparison of acquired values.
Besides, the status of ulcer depth was checked on each examination by free assessment (deep, medium deep, shallow) and also status of granulation tissue (pale, saturated with blood).
Patients and Acquired Results
The research included 39 patients, 17 male and 22 female patients. The average age of the above patients was 60,7 years. 16 patients were treated in a hospital and 23 in ambulatory conditions. As a rule, the research included patients with ulcers in advanced illness stadium and immune to so far applied therapy. The biggest veined ulcer in this research was 11,300 mm.
| Preview of patients as per diagnoses | ||
|---|---|---|
| 1. Ulcera venosa postphlebitica | 31 | (79,5%) |
| 2. Malum perforans pedis | 2 | (5,1%) |
| 3. Ulcu trophicum | 3 | (7,7%) |
| 4. Ulcus mixtum ( arterio - veined) | 2 | (5,1%) |
| 5. Epidermolysis bullosa hereditaria | 1 | (2,6%) |
| Total | 39 | (100,0%) |
Acquired Results:
| 1. Ulcera venosa postphlebitica | |||
|---|---|---|---|
| result excellent | (epithelisation 100%) | 11 | (28,2%) |
| result very good | (epithelisation over 75%) | 6 | (15,4%) |
| result good | (epithelisation over 50%) | 5 | (12,8%) |
| result medium | (epithelisation over 25%) | 5 | (12,8%) |
| result unsatisfactory | (epithelisation less than 25%) | 1 | (2,6%) |
| deterioration during treatment | 3 | (7,7%) | |
| Total | 31 | (79,5%) | |
| 2. Malum perforans pedis | |||
| result excellent | (epithelisation 100%) | 2 | (5,1%) |
| 3. Ulcera trophica (decubitus type) | |||
| result excellent | (epithelisation 100%) | 2 | (5,1%) |
| result good | (epithelisation over 50%) | 1 | (2,6%) |
| 4. Ulcus mixtum ( arterio - veined) | |||
| result excellent | (epithelisation 100%) | 1 | (2,6%) |
| result good | (epithelisation over 50%) | 1 | (2,6%) |
| 5. Epidermolysis bullosa hereditaria | |||
| result excellent | (epithelisation 100%) | 1 | (2,6%) |
| Total (2+3+4+5) | 8 | (20,5%) | |
Final Assessment
On the basis of the results obtained by objective evaluation it could be concluded that MelOp G balsam in high percentage is very efficient for ulcers epithelisation, which is especially noticeable in ulcerous changes of veined origin: excellent result in 28,2%, very good in 15,4%. Also, final result percentage is satisfactory in the categories "good" (12,8%) and "medium" (12,8%). Unsatisfactory final result has been achieved in one case only (epithelisation under 25%), it was extremely old and spread veined ulcer and in three cases deterioration has been noticed (7,7%) from unknown reasons that required changing of therapy.
MelOp G proved to be very effective in other ulcer cases (2,3,4,5) especially in ulcerous changes of the type malum perforansa and ulcera mixta, which were known as extremely resistant to treatment.
Of course, the research that would include greater number of patients would be necessary for accurate results providing. Extremely good result has been achieved in a patient's erosions healing (it was a very quick healing). It was a case of epidermolysis bullosa hereditaria.
On the basis of all above mentioned it could be concluded that MelOp G balsam is a healing substance, which could be applied in ulcerous deviations treatment of vascular / dermatological aetiology, in their reparation phases that is reduced in high percentage. MelOp G balsam has its positive therapeutic effect even in cases of very severe and old ulcers, which are resistant to any other therapy. Unsatisfactory therapeutic results were achieved in a small number of cases and it had no side effects during application.
Novi Sad, 28.04.1987
Head of Department
Docent Dr. Bozidar Matic
Dermatovenerologist
Clinic Director
Primarius Dr. Zivojin Stanojevic
Dermatovenerologist