An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen
Summary
The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.
Description
Adhesions are a common consequence of abdominal surgery. Trauma and emergency general surgery patients may require an open abdomen and undergo a series of abdominal operations, which may be increasingly complicated by the presence of adhesions. Adhesions appear soon after the initial operation and gradually mature within days. The effects of adhesion development on subsequent surgery may include: increased procedure time; difficulty differentiating, exposing, and accessing tissue planes; and increased risk of inadvertent enterotomy. Complications of adhesions include enteric obstruction and enterocutaneous fistulae. This study will determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the extent and severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Open Abdomen
Intervention
Adhesion Reduction Plan
Location
University of Maryland Medical Center
Baltimore
Maryland
United States
21201-1595
Status
Not yet recruiting
Source
University of Maryland
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01010464
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cell Adhesion Molecules, Neuron-glia
Cell adhesion molecules that mediate neuron-neuron adhesion and neuron-astrocyte adhesion. They are expressed on neurons and Schwann cells, but not astrocytes and are involved in neuronal migration, neurite fasciculation, and outgrowth. Ng-CAM is immunologically and structurally distinct from NCAM.
Cell Adhesion Molecules, Neuronal
Surface ligands that mediate cell-to-cell adhesion and function in the assembly and interconnection of the vertebrate nervous system. These molecules promote cell adhesion via a homophilic mechanism. These are not to be confused with NEURAL CELL ADHESION MOLECULES, now known to be expressed in a variety of tissues and cell types in addition to nervous tissue.
Delivery Of Health Care, Integrated
A health care system which combines physicians, hospitals, and other medical services with a health plan to provide the complete spectrum of medical care for its customers. In a fully integrated system, the three key elements - physicians, hospital, and health plan membership - are in balance in terms of matching medical resources with the needs of purchasers and patients. (Coddington et al., Integrated Health Care: Reorganizing the Physician, Hospital and Health Plan Relationship, 1994, p7)
Medicare Part D
A stand-alone drug plan offered by insurers and other private companies to beneficiaries that receive their Medicare Part A and/or B benefits through the Original Medicare Plan. It includes Medicare Private Fee-for-Service Plans that do not offer prescription drug coverage and Medicare Cost Plans offering Medicare prescription drug coverage. The plan was enacted as the Medicare Prescription Drug, Improvement and Modernization Act of 2003 with coverage beginning January 1, 2006.
Epispadias
A birth defect due to malformation of the URETHRA in which the urethral opening is above its normal location. In the male, the malformed urethra generally opens on the top or the side of the PENIS, but the urethra can also be open the entire length of the penis. In the female, the malformed urethral opening is often between the CLITORIS and the labia, or in the ABDOMEN.
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