Amputation — The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb
Citation(s)
Armstrong DG, Lavery LA, Boulton AJ Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.
Armstrong DG, Lavery LA; Diabetic Foot Study Consortium Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1.
Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R Negative pressure wound therapy for managementof the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013 Dec 18;2(12):276-84. doi: 10.1302/2046-3758.212.2000190. Print 2013.
Karlakki SL, Hamad AK, Whittall C, Graham NM, Banerjee RD, Kuiper JH Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. 2016 Aug;5(8):328-37. doi: 10.1302/2046-3758.58.BJR-2016-0022.R1.
Kotha V, Walter E, Stimac G, Kim P Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Review. Surg Technol Int. 2019 May 15;34:49-55.
Liu X, Zhang H, Cen S, Huang F Negative pressure wound therapy versus conventional wound dressings in treatment of open fractures: A systematic review and meta-analysis. Int J Surg. 2018 May;53:72-79. doi: 10.1016/j.ijsu.2018.02.064. Epub 2018 Mar 16.
Nherera LM, Trueman P, Karlakki SL Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements. Wound Repair Regen. 2017 May;25(3):474-482. doi: 10.1111/wrr.12530. Epub 2017 May 3.
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.