Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study
Becker JM, Dayton MT, Fazio VW, Beck DE, Stryker SJ, Wexner SD, Wolff BG, Roberts PL, Smith LE, Sweeney SA, Moore M. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996 Oct;183(4):297-306. PMID: 8843257.
A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial
Glickman M, Gheissari A, Money S, Martin J, Ballard JL; CoSeal Multicenter Vascular Surgery Study Group. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial. Arch Surg. 2002 Mar;137(3):326-31; discussion 332. doi: 10.1001/archsurg.137.3.326. PMID: 11888460.
Assessment of the effect on blood loss and transfusion requirements when adding a polyethylene glycol sealant to the anastomotic closure of aortic procedures: a case-control analysis of 102 patients undergoing Bentall procedures
Natour E, Suedkamp M, Dapunt OE. Assessment of the effect on blood loss and transfusion requirements when adding a polyethylene glycol sealant to the anastomotic closure of aortic procedures: a case-control analysis of 102 patients undergoing Bentall procedures. J Cardiothorac Surg. 2012 Oct 8;7:105. doi: 10.1186/1749-8090-7-105. PMID: 23043723; PMCID: PMC3477041.
A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery
Renkens KL Jr, Payner TD, Leipzig TJ, Feuer H, Morone MA, Koers JM, Lawson KJ, Lentz R, Shuey H Jr, Conaway GL, Andersson GB, An HS, Hickey M, Rondinone JF, Shargill NS. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine (Phila Pa 1976). 2001 Aug 1;26(15):1645-50. doi: 10.1097/00007632-200108010-00002. PMID: 11474348.
Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery
Nasso G, Piancone F, Bonifazi R, Romano V, Visicchio G, De Filippo CM, Impiombato B, Fiore F, Bartolomucci F, Alessandrini F, Speziale G. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009 Nov;88(5):1520-6. doi: 10.1016/j.athoracsur.2009.07.014. PMID: 19853105.
Cost-consequence analysis of two different active flowable hemostatic matrices in spine surgery patients
Makhija D, Rock M, Ikeme S, Kuntze E, Epstein JD, Nicholson G, Price JS, Patel V. Cost-consequence analysis of two different active flowable hemostatic matrices in spine surgery patients. J Med Econ. 2017 Jun;20(6):606-613. doi: 10.1080/13696998.2017.1292916. Epub 2017 Mar 12. PMID: 28287015.
Adept (icodextrin 4% solution) reduces adhesions after laparoscopic surgery for adhesiolysis: a double-blind, randomized, controlled study
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Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group
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Indications and Important Risk Information
FLOSEAL Hemostatic Matrix Indication
FLOSEAL Matrix is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Full important risk information
Do not inject or compress FLOSEAL Matrix into blood vessels. Do not apply FLOSEAL Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.
Do not use FLOSEAL Matrix in patients with known allergies to materials of bovine origin. Do not use FLOSEAL Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges.
FLOSEAL Matrix contains Thrombin made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
FLOSEAL Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Excess FLOSEAL Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application.
FLOSEAL Matrix swells by approximately 10% to 20% after product is applied. Maximum swell volume is achieved within about 10 minutes.
The safety and effectiveness of FLOSEAL Matrix has not been established in children under 2 years of age and pregnant women.
Do not use air to remove residual FLOSEAL Matrix from Applicator tip. The Applicator tips should not be cut. Do not use FLOSEAL Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
FLOSEAL Full Instructions for Use:
INDICATIONS FOR USE:
SEPRAFILM Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the under-lying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
IMPORTANT RISK INFORMATION
SEPRAFILM Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of SEPRAFILM. SEPRAFILM Adhesion Barrier is contraindicated for use wrapped directly around a fresh anastomotic suture or staple line; as such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis). SEPRAFILM Adhesion Barrier must be used according to the instructions for use. SEPRAFILM Adhesion Barrier is for single use only, supplied sterile and must not be re-sterilized. Every opened and unused SEPRAFILM pouch must be discarded. Do not use product if pouch is damaged or opened. The number of sheets used should be just adequate to cover the under surface of the abdominal wall or uterine incision in a single layer.
In patients who have ovarian, primary peritoneal or fallopian tube malignancies, SEPRAFILM use has been reported to have an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required.
The safety and effectiveness of SEPRAFILM Adhesion Barrier has not been evaluated in clinical studies for the following: Patients with frank infections in the abdominopelvic cavity; patients with abdominopelvic malignancy; device placement in locations other than directly beneath an abdominal wall incision following laparotomy, or directly on the uterus following open myomectomy (not laparoscopic); patients with ongoing local and/or systemic inflammatory cell responses; device use in the presence of other implants, e.g. surgical mesh; patients requiring re-operation within four weeks of SEPRAFILM placement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with SEPRAFILM Adhesion Barrier.
The safety and effectiveness of SEPRAFILM Adhesion Barrier in combination with other adhesion prevention products and/or in other surgical procedures not within the abdominopelvic cavity have not been established in clinical studies.
The safe and effective use of SEPRAFILM Adhesion Barrier in pregnancy and Cesarean section has not been evaluated. No clinical studies have been conducted in pregnant women or women who have become pregnant within the first month after exposure to SEPRAFILM Adhesion Barrier. Therefore, this product is not recommended for use during pregnancy and avoidance of conception should be considered during the first complete menstrual cycle after use of SEPRAFILM Adhesion Barrier.
Long term clinical outcomes such as chronic pain and infertility have not been determined in clinical studies.
RX Only. For safe and proper use of this device refer to the complete Instructions for Use.
ADEPT® Adhesion Reduction Solution [4% Icodextrin] Indications
ADEPT Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.
Important Risk Information for ADEPT®
ADEPT® is for direct intraperitoneal administration only. NOT for intravenous (IV) administration.
ADEPT® is contraindicated in patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with
maltose or isomaltose intolerance, or with glycogen storage disease.
ADEPT® is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with
frank abdomino-pelvic infection.
There have been rare reports of sterile peritonitis following the use of icodextrin.
Leakage of ADEPT® from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage
through laparoscopic port sites post-operatively.
There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia.
Anaphylaxis has been reported in a few patients.
Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose
systems that are not glucose specific.
In the pivotal study, the most frequently occurring treatment related adverse events between surgeries were post procedural
leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.
Rx Only: For safe and proper use of this device, please refer to full device Instructions For Use.