Abstract :
I read with interest the article on outpatient management of burn wounds published in a recent issue of the
IJMS.1 There are many questions that arise which are worth mentioning. Under the methodology section,
no description was provided on how patients were randomized into the two treatment arms and, therefore,
it is not possible to assess how confounding variables were controlled. Based on the data presented in table
3 of the article, the pain score before dressing was significantly lower in the “amnion group” than the
“control group”. This might reflect degrees of bias in assigning patients to the study groups. Consequently,
as expected, the pain score measured after dressing and the dose of analgesics consumed were lower in
the “amnion group” than in the “control group” (table 3 of the article).
Another point to be mentioned is that according to Article 32 of the Declaration of Helsinki code of
ethics,2 “the benefits, risks, burdens and effectiveness of a new intervention must be tested against
those of the best current proven intervention.” While numerous brands of synthetic dressings have
been readily available in Shiraz, where the principal investigator practices, it is not clear why the researchers
treated the control group with silver sulfadiazine ointment.
Under the methodology section, it is also not clear how the amniotic membrane was processed; it is
stated that “the amniotic membranes were placed in a sterile pot containing normal saline and 80 mg gentamicin,”
but the volume of normal saline is not mentioned. Did the authors think that an undetermined dose
of gentamicin could eradicate all possible infectious organisms? “VDRL, HIV, and HCV and HBS antigens”
were tested; the membranes were also cultured for identifying probable bacteriologic contamination. Did all
these efforts eliminate the likelihood of transmission of infectious diseases?
As the authors, themselves, state in the very first paragraph of the Discussion, dressing with the
amniotic membrane was introduced almost a century ago, but for concerns about the transmission of
infections, it soon became obsolete in most developed countries. Nonetheless, based on its physiologic
properties, synthetic dressings have been manufactured and used widely. The authors do not
explain why their patients who were treated with amniotic membrane developed a “relatively high fever”
for a few days soon after application of the membrane. As authors mentioned, amniotic membrane
does not cause serious inflammatory response; so what was the cause of that fever? Have
these patients been followed up for a reasonable period of time to identify whether they developed any
health problem? Although it is mentioned that all the participants provided informed consents to take
part in this study, because of marked differences between the knowledge of physicians and patients, it
is not acceptable to put the patients’ health in danger. Note that Ravishanker, whose work had probably
influenced the authors of this article, used long-term glycerol preserved amniotic membranes for
dressing since glycerol has antibacterial and antiviral properties.3 Furthermore, Ravishanker used the
membranes only for dressing of superficial wounds.
Finally, I believe that the Ethical Committee of Shiraz University of Medical Sciences is the most
responsible body in this study for approving conduction of such an appalling and sketchy clinical trial.
Over the past decade, we have witnessed an increasing trend in the number of scientific and biomedical
publications from Iran.4 Thanks to incorporation of many Iranian journals in major indexing systems,
most of our publications are now readily accessible to the entire world. The world community
judges us by our work. Doing a misconduct,5 publishing a plagiarized article,6 or conducting a poor research
will seriously jeopardize this national movement.7 I, for one, believe that all the bodies supervising
research activities in our country should be more cautious in managing this critical situation.
