Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.
Easterlin B, Bromberg W, Linscott J A Novel Technique of Vacuum-assisted Wound Closure That Functions as a Delayed Primary Closure. Wounds. 2007 Dec;19(12):331-3.
Exton RJ, Galland RB Major groin complications following the use of synthetic grafts. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):188-90. Epub 2007 May 18.
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80.
Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
Ploeg AJ, Lardenoye JW, Peeters MP, Hamming JF, Breslau PJ Wound complications at the groin after peripheral arterial surgery sparing the lymphatic tissue: a double-blind randomized clinical trial. Am J Surg. 2009 Jun;197(6):747-51. doi: 10.1016/j.amjsurg.2008.04.014. Epub 2008 Oct 17.
Weir G The use of a surgical incision management system on vascular surgery incisions: a pilot study. Int Wound J. 2014 Jun;11 Suppl 1:10-2. doi: 10.1111/iwj.12261.
Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
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.
