The Value of Seprafilm Adhesion Barrier

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The Value of Seprafilm Adhesion Barrier

Adhesions represent one of the most common yet underappreciated complications following abdominopelvic surgery.1,2 The clinical repercussions of adhesions extend from asymptomatic presentations to severe, life-altering conditions, including chronic pain, infertility, bowel obstruction and complications in subsequent surgeries.2 They also impose a huge financial burden on the health care system and increase the workload of surgeons and all personnel involved in surgical follow-up care.3 Beyond the direct medical costs, the indirect costs—such as lost productivity/time missed from work and rehabilitative services—further underscore the need for effective preventive strategies.4

This article aims to shed light on the value Seprafilm Adhesion Barrier brings to both patients and healthcare providers by evaluating cost of adhesion-related healthcare burdens. Join us in exploring the intricate balance between cost, care and clinical outcomes in the context of abdominopelvic surgeries. Timothy Rafferty, Associate Director of Marketing, Baxter's Advanced Surgery, will provide an overview of the economic burden of adhesions and the potential cost savings as a result of the utilization of adhesion prevention agents such as Seprafilm Adhesion Barrier.

Introduction

Post-surgical adhesions are one of the most common causes of complications after abdominopelvic surgery potentially leading to female infertility, chronic pelvic pain and small bowel obstruction.2,5 Following abdominopelvic surgery, patients have a lifelong risk for developing adhesions.5 Surgical techniques to avoid adhesion formation have not proven to be sufficient and pharmaceutical approaches for their prevention are even less effective, which means the use of adhesion prevention devices is essential to help mitigate the risk adhesions pose.3 While the possible medical impact of adhesions is well known among surgeons, the extent of the economic ramifications of adhesions is often neglected.3

Almost 1 million

days of care have been attributed to adhesiolysis-related procedures and inpatient expenditures total $2.3 billion6*

*based on 2005 Healthcare Cost and Utilization reports 

The average per patient costs

for adhesive small bowel obstruction were reported in 2023 as €40,467 ($43,419)7*

*Euro to Dollar Conversion as of February 5, 2024

What Are Adhesion Barriers and What Makes Them Important?

What are Abdominopelvic Adhesions?

During abdominopelvic surgeries, intentional or accidental trauma to the serosal surfaces prompts the body's healing process, which can inadvertently lead to the formation of adhesions.8 These fibrous bands of scar tissue develop as part of the inflammatory response, aiming to repair the damaged tissue.8 However, a fibrinous mass that persists beyond the 3 to 5 days required for remesotheliazation can abnormally bind organs and tissues together, causing a range of complications.2,8 Thus, the critical time to prevent or diminish adhesion development is in the initial 3 to 5 days after the surgical procedure.8

Why Is It Important to Help Prevent Abdominopelvic Adhesions?

The prevention of abdominopelvic adhesions is crucial due to their potential to cause pain, bowel obstructions, infertility and complications in subsequent surgeries.2 These issues not only affect the patient's quality of life but also lead to increased healthcare costs due to additional treatments, longer hospital stays and the need for further surgical interventions.2,6 Adhesions remain an important surgical problem, and hospitalization for adhesiolysis leads to a high direct cost burden.6

What Can Surgeons Do to Prevent Post-Surgical Abdominopelvic Adhesions?

While meticulous surgical techniques can minimize tissue damage and reduce the risk of adhesion formation, they cannot eliminate the risk entirely.3,8 The inherent nature of surgical interventions, involving tissue hypoxia/ischemia and dessication, and exposure to foreign materials, predisposes patients to adhesion development.9 Thus, additional preventive measures are essential.3

What Are Adhesion Barriers?

Adhesion barriers represent a pivotal advancement in surgical practice. These are biomaterials designed to be placed between tissues during surgery to prevent the formation of adhesions.8,10

Seprafilm Adhesion Barrier was approved in the United States (US) in 1996 and is available in North America and worldwide.8,10,11 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 underlying 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.10

Seprafilm Adhesion Barrier is applied to the surface of injured tissue and forms a gel coating within 24 to 48 hours of placement.10 The gel acts as physical barrier to separate adjacent serosal tissues during the critical stages of wound repair.8 During the transition from a solid to gel, the volume of the barrier increases, but the swelling does not affect peritoneal tissue or organ function.8 The barrier is resorbed from the site of application within 7 days and does not require removal.8 Radiolabeled studies showed that Seprafilm Adhesion Barrier is totally cleared from the body within 28 days following implantation, and the rapid degradation reduces the risk of a foreign body tissue response.8

Seprafilm Adhesion Barrier can be cut and tailored to fit the size and shape of the surgical area.10 Once in place, it adheres to the tissue and forms a barrier.10 The application process is straightforward and the product is ready to use directly from the packaging.10 In addition, new application methods in hybrid robotic and laparoscopic procedures have further enhanced its utility in facilitating tissue separation and reducing adhesions in a wide variety of surgical scenarios.10

For over 25 years, Seprafilm Adhesion Barrier has been used for adhesion prevention in abdominal and pelvic surgery and has been extensively evaluated in clinical trials.10,11-13 The safety and efficacy of Seprafilm Adhesion Barrier have been evaluated in two (2) randomized, controlled, multicenter trials in abdominal and pelvic surgery.10,12,13 Both studies demonstrated that Seprafilm Adhesion Barrier reduces the incidence and severity of post-surgical adhesions. 10, 12,13

The Cost and Value of SEPRAFILM Adhesion Barrier

While the cost of Seprafilm Adhesion Barrier may vary based on location, quantity and procurement contracts, it is imperative to consider this modest investment (under $500/package) against the backdrop of potential savings in postoperative care. The initial expense is counterbalanced by the potential reduction in complications associated with adhesion formation, highlighting the value of Seprafilm Adhesion Barrier from a cost-benefit perspective. For patients, the use of Seprafilm Adhesion Barrier translates into a significantly lower risk of developing post-surgical adhesions, thereby minimizing the likelihood of adhesion-related complications such as chronic pain and infertility.12, 13

Seprafilm Abdominal Data

Value in Abdominal Surgery

In the initial pivotal study, 183 patients with ulcerative colitis and familial polyposis undergoing colectomy with ileal pouch anal anastomosis and temporary loop ileostomy were enrolled.12 The incidence, extent and severity of adhesions to the underside of the abdominal wall incision were evaluated at the time of ileostomy closure with or without the use of Seprafilm Adhesion Barrier.12 Forty-three of 85 patients (51%) in the intervention group were free of adhesions 8–12 weeks after the procedure versus 6% (5/90) of those who underwent surgery without the adhesion barrier (p<0.00000000001).12 Dense adhesions were reported in only 13 patients (15%) who received Seprafilm Adhesion Barrier compared with 52 patients (58%) in the control group (p<0.0001).12

Seprafilm Pelvic Data

Value in Pelvic Surgery

In a second multicenter, randomized trial in pelvic surgery, 117 women undergoing uterine myomectomy were included.13 The mean number of abdominopelvic locations adherent to the uterus was significantly less in the Seprafilm Adhesion Barrier group [4.98 ± 0.52 sites] as compared with the control group [7.88 ± 0.48 sites] (p<0.0001).13 In addition, patients in the treatment group had a significant reduction in the severity of adhesions (p<0.01), the extent of adhesions (p<0.01) and the area of uterus involved in the adhesions (p<0.02).13

SEPRAFILM Adhesion Barrier: Economic and Operational Benefits

The primary advantage of Seprafilm Adhesion Barrier lies in its proven efficacy in reducing the incidence of post-surgical adhesions, which are among the leading causes of complications such as bowel obstructions and chronic pain following abdominal surgeries.3,6,7 By effectively decreasing the likelihood of these complications, Seprafilm Adhesion Barrier not only enhances patient outcomes but also potentially reduces the need for subsequent adhesion-related interventions. 6,7,14 Clinical studies have shown that the use of adhesion barriers can lead to a reduction in the rate of readmissions for bowel obstructions and other adhesion-related issues, which are both costly and resource-intensive to treat.6,7 In addition, per the Evidence-Based Guidelines from the World of Emergency Surgery Adhesive Small Bowel Obstruction Working Group, the use of adhesion prevention/reduction agents should be considered as part of an adhesion reduction strategy.8 Per the recommendations outlined in these guidelines, Level IA evidence supports the use of Seprafilm Adhesion Barrier to reduce adhesion formation and subsequent reoperations of adhesive small bowel obstruction.14 They also note the use of Seprafilm Adhesion Barrier seems cost effective in open colorectal surgery.14

From an economic standpoint, any potential reduction in abdominopelvic adhesions would translate into considerable cost savings for healthcare providers based on the high costs of treating adhesion-related complications.6,7,15,16 These savings would manifest in various ways, including fewer readmissions, reduced need for additional surgeries and shorter hospital stays. By preventing the formation of adhesions, hospitals may avoid the direct costs associated with treating these complications.7 Moreover, the use of Seprafilm Adhesion Barrier potentially contributes to improved operational efficiencies within healthcare facilities.5 By reducing the incidence of adhesion-related complications, hospitals may maintain a higher turnover of surgical beds and minimize the length of stay for patients.5

Beyond the direct economic benefits, the use of Seprafilm Adhesion Barrier aligns with broader healthcare objectives of improving quality of care and patient satisfaction. Direct medical costs represent only a portion of the actual cost to society represented by lost time from work, reduced productivity and lost pay.4 In addition, by proactively addressing a common source of post-surgical complications, healthcare providers may improve their quality metrics, such as lower readmission rates and enhanced patient outcomes. These improvements are pivotal in an era where healthcare reimbursement is increasingly tied to performance metrics and patient satisfaction scores. Facilities that adopt Seprafilm Adhesion Barrier and similar innovations demonstrate a commitment to advancing surgical care and optimizing patient experiences.

SEPRAFILM ADHESION BARRIER INDICATIONS AND IMPORTANT SAFETY INFORMATION

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 underlying 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 Adhesion Barrier and/or to any component of Seprafilm Adhesion Barrier.

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 supplied sterile and must not be re-sterilized. Seprafilm Adhesion Barrier is for single use only. Every opened and unused Seprafilm Adhesion Barrier 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 Adhesion Barrier 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, such as device use on resected liver surfaces following hepatectomy for malignant liver tumors; 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 Adhesion Barrier 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.

Baxter and Seprafilm are registered trademarks of Baxter International Inc.