Controlled Clinical Trials in Burns
Moist Exposed Burn Ointment (MEBO) in Partial Thickness Burns
A Randomized, Comparative Open Mono-Center Study
Department of Plastic, and Reconstructive Surgery, Helios Klinikum Wuppertal, University of Witten/Herdecke, Germany
Hirsch T, et al. European Journal of Medical Research 2008; 13:505-510
This study demonstrated that MEBO® ointment for topical treatment of burn injuries presents an attractive alternative for the topical treatment of limited partial thickness thermal burns

A New Approach to Local Burn Wound Care: Moist Exposed Therapy. A Multiphase, Multi-center Study
Atiyeh BS, et al.  Journal of Surgical Wound Care 2003; 2(1): 18-27
MEBO® was tested on healing of split thickness skin graft donor sites and compared to semi-open (Sofra Tulle) and a semi-occlusive (Tegaderm) dressing.  Healing with the ointment was observed within 5-8.9 days versus 10-13 days for the other dressings.  Scar assessment scores demonstrated significantly better scars for MEBO® at 1 month (p<0.001) as compared to Tegaderm.  The difference was significant (p<0.05) at 2 and 6 months. 
Subsequently, two clinical trials on burn patients were conducted. MEBO® application resulted in a statistically significant (p<0.001) decrease in overall treatment costs as compared to other topical treatment modalities.  The most significant cost reduction was observed in the utilization of medical facilities (p<0.0001).  The trials elaborated the practicality of MEBO® therapy and its effectiveness in preventing burn wound sepsis.  Initial swab cultures were positive in 29% of the immediately treated patients and 92% in patients treated on the third post burn day.  By the second week, bacterial colonization dropped to 5% and 23% respectively.
It is not conceivable to abandon products and methods currently in use for local burn wound care whose benefits have been well documented unless additional benefits of the new product can well be elaborated.  Our first concern was to demonstrate that the new moisture retentive ointment has a good antibacterial effect.  Second, it was important to prove its moisture retentive capacity and its positive impact on wound healing as it applies to burn wounds.  Third, it was crucial to determine whether the use of this ointment could be practical and cost-effective.

Though it is not an antibiotic, adequate local antibacterial action of the ointment has been demonstrated in a previously reported experimental study.  In a parallel study it was shown that prolonged use of MEBO
® does not seem to lead to the emergence of resistant strains.  Improved healing potential of the ointment has been demonstrated in previous clinical studies.  The clinical value of the moisture retentive ointment in autolytic debridement and healing of burn wounds has been elucidated in clinical trial 1.  Clinical trial 2, on the other hand, stressed the practicality and cost-effectiveness of the ointment in local wound care.  Adverse side effects to the ointment was observed in clinical trial 1 in only one female patient who developed itching and presented with flushing of her face following the second day of application.  All symptoms subsided as soon as application was discontinued.
MEBO Ointment in the Treatment of Burn Wounds: A Multi-center Study
Dham R, et al.  Modern Med Mid East 1999, 16(8):46-50
One hundred and thirty-eight (138) patients, with five hundred and sixty-six (566) different burn sites with different degrees, severity and locations, were enrolled to a multicenter clinical trial at 25 study centers.  The aim of this study was to explore the therapeutic effectiveness of MEBO® and to gain more experience in its use in the Middle East.  Various parameters were studied including: (i) healing time, (ii) need for pain killers, (iii) consumption of intravenous fluids, (iv) use of systemic antibiotics and (v) aesthetic appearance.  There was remarkable decrease in the healing time and most patients either did not need any pain killer or were relieved with only mild analgesics, except in few cases of deep second degree and third degree burns.  A decrease in the volume of intravenous fluids needed was also reported.  Only 19% of cases developed clinical infection, especially in those who were not treated with MEBO® immediately post burn.
 Even though systemic antibiotic treatment was prophylactically implemented in most cases as a routine measure, 32 cases did not receive any antibiotic prophylaxis with MEBO® and yet did not develop any infection.  The aesthetic appearance reported was very acceptable.  This treatment modality was not associated with any side effects, and patient discomfort during application and change was negligible.  Thus, MEBO® treatment was associated with excellent and relatively faster healing, low incidence of wound infection, and excellent patient compliance.

The Role of Alternative Therapy in the Management of Partial Thickness Burns of the Face - Experience with the Use of MEBO Compared with Silver Sulphadiazine
Ang ES, et al. Ann Acad Med Singapore 2002; 29(1): 7-10
The use of MEBO® for partial thickness burns of the face resulted in similar healing rates compared to that achieved with silver sulphadiazine dressings.  It is a cheaper alternative, both in terms of hospital costs and consumables, but required increased manpower time for dressing.  It is easier to apply and allows better assessment of the progress of the underlying wound healing compared to silver sulphadiazine.  This suggests that MEBO® is a useful alternative modality in the management of partial thickness burns of the face. 

Evaluating the Role of Alternative Therapy in Burn Wound Management: Randomized Trial Comparing MEBO with Conventional Methods in the Management of Patients with Second-degree Burns
Ang ES, et al. Medscape General Medicine 2001; 3(12):3-18
This trial demonstrates similar outcomes when partial-thickness burns covering less than 40 % BSA are treated with C or MEBO®.  Time taken for 75 % of the original BSA to epithelialize was taken as the end point for in-hospital healing in our study.  Patients treated with MEBO® took 17 days on average to heal vs 20 days when on C.  The rate of MRSA presence in MEBO® wounds was similar to that in C wounds.  In addition, Acinetobacter baumannii and Pseudomonas aeruginosa, 2 gram-negative organisms that pose a particular problem in our Burns Center, continued to persist in the MEBO®-treated wounds as compared with the relative absence of these organisms by the second week postburn in C wounds.  This shows that MEBO® is not bactericidal against potentially pathogenic microorganisms as previously claimed.
With regard to pain control, MEBO® imparts a greater analgesic effect than that afforded by C, especially in the first 5 days following injury.  Effective pain relief during this period is advantageous to modulate the acute immune response.  This is reflected by the increased number of patients requesting opiate analgesics in the C group and the more than double mean dose of Pethidine administered in the first week to this group.  The analgesic effect is attributable to the presence of the layer of ointment that shields the burn wound from the external environment.  Notably, as therapy progressed, this analgesic advantage was reduced, possibly due to the daily removal of accumulated MEBO® at this stage.
From a practical standpoint, a straw poll of the nurses indicated that they found it easier to manage facial and neck burns with MEBO®, as it did not require the elaborate bandaging that is required with silver sulfadiazine.  Additionally, occupational therapy in MEBO®-managed hand burns was instituted earlier as there was no hindrance from bulky dressings, thus improving rehabilitation prospects in these cases.
From the results of this prospective randomized, controlled trial, it is concluded that MEBO® is as effective as the conventional approach in the management of second-degree burns, though it is not the panacea for all burn wounds as claimed.  It may be useful alternative in burn injuries involving certain anatomical sites such as the face, neck, and hands.  MEBO® is less expensive than conventional treatment and provides better pain relief in the first 5 days after burns.  In addition, as MEBO® is conveniently stored in large quantities, portable, easily dispensable, and applied even by semiskilled personnel, its use may be advantageous in mass casualty situations before evacuation to definitive burn care facilities.
Benefit-Cost Analysis of Moist Exposed Burn Ointment
Atiyeh BS, et al. Burns 2002; 28:659-663
The study has shown that patients not treated with MEBO® application required statistically significant longer hospitalization.  It has shown also that the increased daily cost of MEBO® ointment, though statistically not significant, is largely offset by the 60% increase in cost of dressing and medical materials required by other topical therapy modalities which is extremely significant.  The combination of longer hospitalization and increased cost of conventional dressings clearly demonstrate the positive benefit of MEBO® application in the topical treatment of minor to moderate second degree burns over conventional standard methods of local treatment whenever early surgical tangential excision and skin grafting is not feasible or warranted. 
The present study does not allow, however, extrapolation of these positive results to more extensive or deeper burns.  Moreover, the limitation of computation of cost of management to the period necessary for healing and re-epithelialization alone without considering the future cost of rehabilitation after actual wound healing and the cost of secondary corrective procedures may not give a realistic idea about the total actual cost of the local therapeutic modalities under study, particularly since different scar qualities may be expected.  Though scarring was not evaluated in the present study and its impact on the need of secondary corrective therapies with their obvious effect on total cost was not assessed, it has been previously shown that better scar quality may be expected following treatment of partial thickness wounds with MEBO®.  This may mean that resultant scars following MEBO® application may require less scar related treatment modalities and perhaps less secondary corrective procedures that by itself may make MEBO® application even more cost beneficial. 
Within the limits of the study, MEBO® has been shown to be a cost beneficial alternative in the local management of minor to moderate second degree burns.  Benefit-cost analysis evaluating only the financial elements of a program is based on the assumption that the goal of a health care program is to save money.  This raises serious philosophical and ethical concerns.  The goals of health care must be to add years to life and life to years, in other words, to increase the quantity and quality of life that is practically impossible and even inappropriate to price tag.  From that particular perspective, the positive effects of MEBO® expressed in terms of analgesia, psychological comfort, ease of application and better healing and scarring as demonstrated by previous studies adds tremendously to the benefit-cost analysis.

Cost-Effectiveness of Moist Exposed Burn Therapy
Atiyeh BS, et al. J Burns & Surg Wound Care, 2004; 3(1): 3-12

In the present study, a very significant earlier spontaneous healing of second degree burns was achieved with the moist exposed therapy at a lesser cost of most of the measured parameters, even though some differences were not statistically significant probably due to the small size of the study and control groups.  Overall total treatment cost was also significantly reduced by MEBO® with a significant reduction of the physicians work load, and a very significant reduction of the nurses work load.  The exact benefit of the reduction in work load and time spent with the burned patients by the concerned health personnel cannot be evaluated by the present study which only estimates the cost of labor affected. 

Measures to estimate the added benefits that may be derived from investing the health personnel during the saved time in other beneficial actions with other patients might only add to the cost-effectiveness of the moist exposed therapy and is an important parameter that must be considered in future cost-benefit studies.  Even though no significant difference between the cost of MEBO® and that of the other topical agents was observed, when the cost of dressings is added to the cost of topical materials, the extent of savings realized by moist exposed therapy without an overlying dressing become clearly evident.  Moreover, better scar quality following primary and secondary healing with moisture retentive ointment application has already been reported.  This may mean that resultant scars following MEBO® application may require fewer scars related treatment modalities and perhaps less secondary corrective procedures that by itself may make MEBO® application a more cost beneficial local burn wound care modality. 

MEBT is a valid alternative to local care of second degree burn wounds.  In a previously published study, MEBO® has been found to be a cost-beneficial alternative in the local management of minor to moderate second degree burns.  Results of the present study confirm these earlier observations.  Moreover, in addition to being less labor intensive, MEBT results in actual direct savings appreciated by all health care systems.  Its real value, however, can be appreciated better if the reduction in estimated losses due to poor healing and scarring are accounted for.  Positive investment of the saved physiciansĄŻ and nursesĄŻ time adds further to the cost-effectiveness of this new local burn wound care modality.

Clinical Trial Report of Burns Regenerative Medicine and Therapy ¨C a Multi-center Phase III Study
Xu RX. Burns Regenerative Medicine and Therapy, 1st ed., Basel: Karger; 2004. p. 119-128
In order to further examine and evaluate the therapeutic effects, main indications, and possible side effects of MEBO® in burn treatment, this multi-center study was conducted as a phase III clinical trial.  In this trial, MEBO® was used for treating vast numbers of burn patients of both sexes in varied ages, all suffering burns from different causes, occurring at different sites, encompassing varied areas, and injured to varied depths.  From January 1, 1996 to June 30, 1999, this phase III clinical trial was carried out at five burn centers of the China National Science and Technology Center for Burns, Wounds and Ulcers, located in Changsha, Taishan, Dalian, and Nanyang, China. 
Effects of MEBO® on Burns Wounds Management: According to the results of this trial, MEBO® promotes burn wounds healing in each depth of wound.  Remarkably, 99% of deep partial-thickness burn wounds healed spontaneously without skin grafting, at a very low scarring rate of 20.4% compared to 63.3% in the SD-Ag group.  Furthermore, in this trial, more than half of the clinically diagnosed full-thickness burns wounds could be healed spontaneously by MEBO® without skin grafting.  MEBO® provided burn wounds an optimum physiological environment for tissue regeneration and repair without further damage to viable tissue, subsequently, the wound would heal spontaneously with limited scarring, deformity, and disability.  Meanwhile, it was found that in the MEBO® group, the incidence rate of wound infection was significantly reduced compared to that in the SD-Ag group, indicating that MEBO® was capable of preventing wound infection.
Analgesic Effect of MEBO®: It was determined in this trial that throughout the treatment and during dressing changes, the analgesic effect and alleviation of pain in the MEBO® group was dramatically superior to that of in the SD-Ag group.  Unlike SD-Ag which required painful peeling away of crusted and dried dressing from fragile tissue, MEBO® neither aggravated the suffering and pain during the treatment and changing of dressing, nor did it fail to offer a satisfactory analgesic effect.  The need for an analgesic agent was rare in MEBO® group.
Feasibility of Using MEBO® for Treating Extensive Burns: In this trial, 75 extensive burn patients with TBSA >50% were treated with MEBO® which resulted in a 100% healing rate whereby all patients were completely healed when discharged from the hospital.  No side effects and local or systemic allergic reactions were found.  In contrast, 2 of 31 extensive burn patients in the SD-Ag group died and 18 patients were discharged with unhealed residual wounds. 
Meanwhile, almost half of the extensive burns patients in the SD-Ag group were failing the treatment due to complications of wound infection, bleeding, severe painful or delayed healing, and had to switch into the MEBO® group for ethical reasons, and, despite the relatively late access to MEBO®, these patients achieved the same satisfactory results.  Therefore, it was concluded that treatment with MEBO® for extensive burn patients was practical and safe.  In addition, it indicated that when the treatment with SD-Ag for extensive burn patients appeared to be unsatisfactory, switching them to MEBO® was appropriate.  MEBO® seemed to promote spontaneous healing in delayed-healing wounds and was able to free or decrease the needs of grafting.
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