Acellular Dermal Matrix in Breast Reconstruction — Comparing AlloDerm and DermACELL in Breast Reconstruction
Citation(s)
Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plast Reconstr Surg. 2017 Mar;139(3):521-528. doi: 10.1097/PRS.0000000000003048.
Steiner CA, Weiss AJ, Barrett ML, Fingar KR, Davis PH Trends in Bilateral and Unilateral Mastectomies in Hospital Inpatient and Ambulatory Settings, 2005-2013. 2016 Feb [updated 2016 Mar 1]. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #201. Available from http://www.ncbi.nlm.nih.gov/books/NBK367629/
Zenn MR, Salzberg CA A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Eplasty. 2016 Aug 11;16:e23. eCollection 2016.
Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
