Celebrating a prospective randomised control trial

Celebrate a prospective randomised control trial

M Felix freshwater
Voluntary Professor of surgery, University of Miami School of Medicine, 9100 s. Dadeland Blvd. Suite 502, Miami, FL 33156-7815, United States

Letters mailing address:
M Felix freshwater
Voluntary Professor of surgery, University of Miami School of Medicine, 9100 s. Dadeland Blvd. Suite 502, Miami, FL 33156-7815
United States

How to cite this article:
Freshwater MF. Celebrate a prospective randomised control trial. Indian J Plast Surg 2012; 45: 38-9

I am writing this comment on April 1, known as the April Fool's Day in the United States. Historically, it is a day of pranks played on people, printing, and is now also online. [1], [2], [3] [4].

If I were to say that was the preceding article of evidence-based medicine of better quality than the latest article on the subject will appear in the Journal, Hand Surgery, you would think that I drag an April Fool's prank you.

It is not a prank. It is the truth. Published ahead of print and available online in the journal of Hand Surgery, but not yet indexed in PubMed, is a retrospective study from Harvard Medical School/Massachusetts General Hospital. [5]

The importance of this study in the Indian Journal of plastic surgery cannot be sufficiently stressed. Why?

Not only is it a higher quality study than that from Massachusetts General Hospital, but is also discovered I, using database PubMed, that this is the first randomized controlled blinded trial to be published in this journal.

It is most impressive that writers began this study, almost ten years ago, before the concept of evidence-based medicine became au courant among our confreres.

One can quibble with certain aspects of that approach, for example, distributing alternating patients to control and treatment arms, pseudo-stickprovsmetoder. [6] in 2012 is random number generators, freely available on the internet. However, the distribution of points worth noting about this study:

That the authors tried to respond to a meaningful clinical question rather than continuing to employ the dogma which they had learned from their professorsThat, the authors continued in an ethical manner by obtaining approval from its institutional ethics committeeThat the authors clearly described the informed consent obtained from their patientsThat the results were measured by an independent therapist who was blind treatment armsThe ethical standards which the authors were included in the Declaration of Helsinki. Only ethical requirement that the authors did not meet, IJPS and Declaration of Helsinki now requires that all prospective trials shall be registered in a publicly accessible database before the first patient enrolled in. [7] the Trial registration is free.

With the wealth of patients who need treatment for their hand problems, Indian plastic surgeons has a golden opportunity to not only help their patients, but also for answering important clinical questions with high-quality, ethics, future, Blind randomised controlled trials. [8]

These authors have Indian pioneers. Others should follow in their footsteps.

 

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Fat-Derived Stem Cells Show Promise for Regenerative Medicine, Says Review in Plastic and Reconstructrice Surgery (R)

ARLINGTON HEIGHTS, ill., may 29, 2012 (GLOBE NEWSWIRE)--Adipose stem cells (ACSs) — stem cells derived from fat — is a promising source of cells for Use in plastic surgery and regenerative medicine, according to a special review in the June issue of plastic and reconstructive surgery ?, the official medical journal of the American Society of plastic surgeons (ASPS).

However, much more research is needed to establish the safety and effectiveness of any type of ASC therapy in human patients, in accordance with article ASP member surgeon Rod Rohrich, MD University of Texas Southwestern Medical Center, Dallas, and colleagues. Dr. Rohrich is editor in Chief of plastic and reconstructive surgery.

Adipose stem cells – exciting opportunities, but proceed with caution

The authors present an up-to-date review of the research on the science and clinical application of ASCs. Relatively simple derived from human fat, ASCs are "multipotent" cells can induce that develop into other types of cells – not only fat cells, but also bone, cartilage and muscle cells.

Adipose stem cells promote the development of new blood vessels (angiogenesis) and seems to represent a "immune privileged" set of cells that block inflammation. "Clinicians and patients both have high expectations that ASCs may be the answer to cure many recalcitrant diseases or to reconstruct the anatomical defects," according to Dr. Rohrich and other co-authors.

Although the number of studies using ASCs are rising, there are, however, continuing concerns about their "real clinical potential." The reviewers write, "for example, there are questions about the isolation and purification of ASCs and their effect on tumor growth and execution of FDA regulations."

Dr. Rohrich and other co-authors conducted an in-depth review to identify all known clinical trials of ASCs. So far, most studies conducted in Europe and Korea; reflect strict FDA regulations, has only three ASC studies conducted in the United States to date.

Many different uses, but little experience so far

Most ASC clinical trials to date have been carried out in plastic surgery – a field with "unique privileged access to fat tissue." Plastic surgeon-researchers have used ASCs for various types of soft tissue augmentation, breast augmentation (including after implant removal) and the regeneration of fat in patients with abnormal fat loss (lipodystrophy). Studies exploring the use of ASCs to promote healing of difficult wounds have been reported as well. They have also been used as a method for soft tissue engineering and tissue regeneration, with questionable results.

In other specialties, ASCs have been studied for use in the treatment of some blood and immunological disorders, heart neurological and vascular problems, and fistulas. Some studies have explored the use of ASCs to generate new bones for use in reconstructive surgery. Some studies have reported promising preliminary results in the treatment of diabetes, multiple sclerosis and spinal cord injury. No serious adverse events related to the ASCs was reported in any of the groups of studies.

Although many of the results are encouraging, emphasize the reviewers to all these programmes is in its infancy. Around the world, for all uses, less than 300 patients treated with any standard protocol for preparation or clinical applications of ASCs.

There is also no consensus on the number of ASCs are required per treatment, or how many treatments are necessary to show clinical improvement. Consequently, Dr. Rohrich and co-author conclude "further fundamental science experimental studies with a standardized protocol and larger randomized controlled trials must be carried out to ensure the safety and effectiveness of ASCs in accordance with FDA guidelines."

Plastic and reconstructive surgery ? is published by Lippincott Williams & Wilkins, part of Wolters Kluwer Health.

LaSandra Cooper or Marie Grimaldi
American Society of plastic surgeons
847-228-9900
Media@plasticsurgery.org
www.plasticsurgery.org

Plastic and reconstructive surgery

More than 60 years, plastic and reconstructive surgery ? (http://journals.lww.com/plasreconsurg/), a consistently excellent reference for each specialist who uses plastic surgery techniques or work with a plastic surgeon. American Society of plastic surgeons, plastic and reconstructive surgery ?, the official journal provides subscribers with up-to-the-minute reports on the latest technology and monitoring for all areas of plastic and reconstructive surgery, including breast reconstruction, experimental studies, maxillofacial reconstruction, hand and microsurgery, burn repair, and cosmetic surgery, as well as news about medico-legal issues.

About ASP

American Society of plastic surgeons (ASPS) is the world's largest organization for specialty plastic surgeons. Representing more than 7,000 Member Surgeons, the society is recognized as a leading authority and information source on aesthetic and Reconstructive plastic surgery. ASPS comprises more than 94 percent of all specialty plastic surgeons in the United States. Founded in 1931, and represents the society physician certified by the American Board of plastic surgery or The Royal College of Physicians and Surgeons of Canada. ASP advances the quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery. You can learn more and visit the American Society of plastic surgeons at Facebook.com and Twitter.com PlasticSurgery.org or/PlasticSurgeryASPS/ASPS_news.

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