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      Seprafilm® adhesion barrier: (1) a review of preclinical, animal, and human investigational studies

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          Abstract

          The aim of this study was to provide a single site resource for investigators, clinicians, and others seeking preclinical, animal, and human investigational studies concerning the postsurgical, anti-adhesion barrier Seprafilm™ (Genzyme Corporation, Cambridge, MA). All published preclinical, animal, human extra-abdominal research as of July 2011 have been summarized and included in this document. Searches of Medline and EMBASE Drugs and Pharmaceuticals databases were conducted for original preclinical, animal, and human extra-abdominal studies involving Seprafilm. Preclinical, animal, and extra-abdominal human investigational studies are the study selection for this manuscript. Intraabdominal use is discussed in the accompanying manuscript. Data extraction includes systematic manuscript review. Summary of preclinical, animal, and extra-abdominal human investigational use of Seprafilm by surgical discipline were gathered for data synthesis. The clinical use of Seprafilm, which was approved by the FDA for intra-abdominal procedures, is supported by preclinical and animal studies relating to general surgical and obstetrical/gynecological applications. Findings from preclinical, animal, and human investigational studies at other sites throughout the body raises the potential for additional human clinical trials to assess efficacy and safety following surgical procedures at non-abdominal locations.

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          Most cited references 83

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          Abdominal adhesions: current and novel therapies.

          An adhesion occurs when two tissues that normally freely move past each other attach via a fibrous bridge. Abdominal adhesions place a tremendous clinical and financial burden on public health. Adhesions develop after nearly every abdominal surgery, commonly causing female infertility, chronic pelvic pain, and, most frequently, small bowel obstruction. A National Hospital Discharge Survey of hospitalizations between 1998 and 2002 reported that 18.1% of hospitalizations were related to abdominal adhesions annually accounting for 948,000 days of inpatient care at an estimated cost of $1.18 billion. This review discusses the current or proposed therapies for abdominal adhesions. While many therapies for abdominal adhesions have been attempted, the need for a definitive therapy to prevent or even reduce abdominal adhesions still exists. Copyright © 2011 Elsevier Inc. All rights reserved.
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            Sciatica of nondisc origin and piriformis syndrome: diagnosis by magnetic resonance neurography and interventional magnetic resonance imaging with outcome study of resulting treatment.

            Because lumbar magnetic resonance (MR) imaging fails to identify a treatable cause of chronic sciatica in nearly 1 million patients annually, the authors conducted MR neurography and interventional MR imaging in 239 consecutive patients with sciatica in whom standard diagnosis and treatment failed to effect improvement. After performing MR neurography and interventional MR imaging, the final rediagnoses included the following: piriformis syndrome (67.8%), distal foraminal nerve root entrapment (6%), ischial tunnel syndrome (4.7%), discogenic pain with referred leg pain (3.4%), pudendal nerve entrapment with referred pain (3%), distal sciatic entrapment (2.1%), sciatic tumor (1.7%), lumbosacral plexus entrapment (1.3%), unappreciated lateral disc herniation (1.3%), nerve root injury due to spinal surgery (1.3%), inadequate spinal nerve root decompression (0.8%), lumbar stenosis (0.8%), sacroiliac joint inflammation (0.8%), lumbosacral plexus tumor (0.4%), sacral fracture (0.4%), and no diagnosis (4.2%). Open MR-guided Marcaine injection into the piriformis muscle produced the following results: no response (15.7%), relief of greater than 8 months (14.9%), relief lasting 2 to 4 months with continuing relief after second injection (7.5%), relief for 2 to 4 months with subsequent recurrence (36.6%), and relief for 1 to 14 days with full recurrence (25.4%). Piriformis surgery (62 operations; 3-cm incision, transgluteal approach, 55% outpatient; 40% with local or epidural anesthesia) resulted in excellent outcome in 58.5%, good outcome in 22.6%, limited benefit in 13.2%, no benefit in 3.8%, and worsened symptoms in 1.9%. This Class A quality evaluation of MR neurography's diagnostic efficacy revealed that piriformis muscle asymmetry and sciatic nerve hyperintensity at the sciatic notch exhibited a 93% specificity and 64% sensitivity in distinguishing patients with piriformis syndrome from those without who had similar symptoms (p < 0.01). Evaluation of the nerve beyond the proximal foramen provided eight additional diagnostic categories affecting 96% of these patients. More than 80% of the population good or excellent functional outcome was achieved.
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              Prevention of peritendinous adhesions using a hyaluronan-derived hydrogel film following partial-thickness flexor tendon injury.

              Peritendinous adhesions are an important complication of flexor tendon injury. Three hyaluronan (HA)-derived biomaterials were evaluated for the reduction of peritendinous adhesions following partial-thickness tendon injury in rabbits. Rabbits (n = 24) were divided into three groups (n = 8 per group), which were used for gross evaluation, histologic assessment, or biomechanical testing. The fourth and third toes from both hindpaws of each rabbit were randomly assigned to one of four treatments: (i) untreated control, (ii) Seprafilm, (iii) Carbylan-SX in situ crosslinked hydrogel, and (iv) preformed Carbylan-SX film. Rabbits were sacrificed at 3 weeks postsurgery and evaluated anatomically, histologically, and mechanically. All materials used reduced adhesions relative to untreated controls for all three evaluations. Both the gross anatomic and histologic results revealed that Carbylan-SX film was statistically superior to Seprafilm and Carbylan-SX gel in preventing tendon adhesion formation. In biomechanical tests, the Carbylan-SX film-treated hindpaws required the least force to pull the tendon from the sheath. This force was statistically indistinguishable from that required to extrude an unoperated tendon (n = 8). Carbylan-SX gel was less effective than Carbylan-SX film but superior to Seprafilm for all evaluations. A crosslinked HA-derived film promoted healing of a flexor tendon injury without the formation of fibrosis at 3 weeks postoperatively. (c) 2007 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.
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                Author and article information

                Contributors
                +1-313-9934523 , +1-313-9934534 , mdiamond@med.wayne.edu
                Journal
                Gynecol Surg
                Gynecol Surg
                Gynecological Surgery
                Springer-Verlag (Berlin/Heidelberg )
                1613-2076
                1613-2084
                20 April 2012
                20 April 2012
                September 2012
                : 9
                : 3
                : 237-245
                Affiliations
                [1 ]Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Wayne State University, 60 West Hancock, Detroit, MI 48201 USA
                [2 ]Genzyme Corporation, Cambridge, MA USA
                Article
                741
                10.1007/s10397-012-0741-9
                3401296
                22837732
                © The Author(s) 2012
                Categories
                Review Article
                Custom metadata
                © Springer-Verlag 2012

                Obstetrics & Gynecology

                adhesiolysis, seprafilm, postoperative adhesions, anti-adhesion adjuvant

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