Cesarean Section Complications — PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Citation(s)
ACOG Practice Bulletin No 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
Acosta S, Bjorck M, Wanhainen A Negative-pressure wound therapy for prevention and treatment of surgical-site infections after vascular surgery. Br J Surg. 2017 Jan;104(2):e75-e84. doi: 10.1002/bjs.10403. Epub 2016 Nov 30.
Gillespie BM Prophylactic Use of Negative Pressure Wound Therapy After Cesarean Delivery. Obstet Gynecol. 2015 Jul;126(1):214. doi: 10.1097/AOG.0000000000000937. No abstract available.
Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
Leth RA, Uldbjerg N, Norgaard M, Moller JK, Thomsen RW Obesity, diabetes, and the risk of infections diagnosed in hospital and post-discharge infections after cesarean section: a prospective cohort study. Acta Obstet Gynecol Scand. 2011 May;90(5):501-9. doi: 10.1111/j.1600-0412.2011.01090.x. Epub 2011 Mar 14.
Searle RJ, Myers D A survey of caesarean section surgical site infections with PICO Single Use Negative Pressure Wound Therapy System in high-risk patients in England and Ireland. J Hosp Infect. 2017 Oct;97(2):122-124. doi: 10.1016/j.jhin.2017.02.023. Epub 2017 Aug 12.
Strugala V, Martin R Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.
Yu L, Kronen RJ, Simon LE, Stoll CRT, Colditz GA, Tuuli MG Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Feb;218(2):200-210.e1. doi: 10.1016/j.ajog.2017.09.017. Epub 2017 Sep 23.
PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
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.