What is Seprafilm Adhesion Barrier? 

The field of medicine, and more specifically surgery, is one that is continuously evolving with every advancement in technology and biotechnology. One significant milestone in the realm of surgical interventions is the development of bioresorbable adhesion barriers. Among them, Seprafilm Adhesion Barrier stands out due to its unique characteristics and potential benefits.^1,2 This biomaterial has revolutionized the way surgeons approach and manage surgical procedures, specifically in mitigating post-surgical adhesion formation.^1,2

This article aims to look into Seprafilm Adhesion Barrier, exploring its intricacies, and shedding light on its use and importance in modern surgical practices. Whether you're already familiar with this adhesion barrier or hearing about it for the first time, this detailed exploration serves to enhance your understanding and appreciation of its role in improving surgical outcomes. Timothy M. Fulghum, PhD,  Prinicipal Scientist, Baxter’s Advanced Surgery Product Development, will touch on the science behind Seprafilm Adhesion Barrier, its key benefits and recent advancements in application in hybrid robotic and laparoscopic procedures. So, let's journey together into the world of Seprafilm Adhesion Barrier and explore the crucial role it plays in contemporary surgical procedures.

Introduction

Post-surgical adhesions lead to significant patient morbidity such as small bowel obstruction, infertility, chronic pain, and difficult, complicated subsequent surgeries.^2,3 Various strategies, have been put forth to prevent adhesion development including meticulous surgical techniques, pharmacological agents, and new equipment and instrumentation.²  Seprafilm Adhesion Barrier is a bioresorbable membrane composed of sodium hyaluronate (HA) and carboxymethylcellulose (CMC) which have been chemically modified to delay the rate of degradation and clearance after placement in the body for the prevention of post-surgical adhesions.^1,2

Seprafilm Adhesion Barrier is applied to the surface of tissues to be protected and hydrates to form a lubricious gel coating within 24 to 48 hours of placement^1,2

The hydrophilic protective gel acts as physical barrier to separate adjacent serosal tissues during the critical stages of wound repair^1,2

Seprafilm Adhesion Barrier can be cut and tailored to fit the size and shape of the surgical area.¹ Once in place, it adheres to the tissue and forms a barrier.¹ The application process is straightforward and the product is ready to use directly from the packaging. ¹ In addition, new application methods in hybrid (i.e., through open-element incisions) robotic and laparoscopic procedures have further enhanced its utility in facilitating tissue separation and reducing adhesions in a wide variety of surgical scenarios.¹

What is the Indication?  

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.¹

How Does It Work?  

To understand the mechanism of action of Seprafilm Adhesion Barrier, it’s important to have an awareness of peritoneal repair, and what goes awry when adhesions develop.² Adhesions develop in an effort by the body to restore the supply of oxygen and nutrients to tissue that has been injured during the surgical procedure.²  As a result of tissue injury, an inflammatory-like response occurs as a result of surgery-induced tissue hypoxia, with subsequent generation of reactive oxygen and reactive nitrogen species.²  The inflammatory response triggers the release of histamine, cytokines, and growth factors, and draws leukocytes and fibroblasts to the affected area.² Collections of blood and serosanguinous tissue exudates occur on the surface of the injured tissue forming a fibrinous mass.² This process persists during and beyond the 3 to 5 days required for remesotheliazation.² Thus, the critical time to prevent or diminish adhesion development is in the initial 3 to 5 days after the surgical procedure. ²     

Seprafilm Adhesion Barrier is applied to the surface of injured tissue and forms a gel coating within 24 to 48 hours of placement.^1,2 The gel acts as physical barrier to separate adjacent serosal tissues during the critical stages of wound repair. ² During the transition from a solid to gel the Seprafilm does not migrate, but remains at the site of application for approximately 7 days.^1,5 The volume of the barrier increases, but the swelling does not affect peritoneal tissue or organ function.²  The barrier is resorbed from the site of application within 7 days and does not require removal.² 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.^1,2

In animal models, Seprafilm Adhesion Barrier was reported to be efficacious in reducing adhesions, including in the presence of blood and irrigation solution.² When used in multiple layers, Seprafilm Adhesion barrier did not adversely affect wound healing, did not affect anastomotic healing with or without concomitant ischemia and did not potentiate intra-abdominal sepsis.² Concomitant radiotherapy did not alter the efficacy; however, the efficacy of Seprafilm Adhesion Barrier was reduced in the presence of peritonitis.² In addition, per the labeling guidelines, 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).¹ An increased rate of anastomotic leak was identified in a post-approval study when the product was wrapped directly around a fresh anastomotic suture or staple line.¹

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.^1,4,6,7 The safety and efficacy of Seprafilm Adhesion Barrier have been evaluated in two (2) randomized, controlled, multicenter trials in abdominal and pelvic surgery.^1,6,7 Both studies demonstrated that Seprafilm Adhesion Barrier reduces the incidence and severity of post-surgical adhesions. ^1,6,7

Recent advances in Seprafilm Adhesion Barrier application methods have supported its use in hand-assisted, hybrid robotic and laparoscopic procedures for adhesion prevention.¹ Seprafilm Adhesion Barrier is applied through an open-element incision.¹ The product may be folded lengthwise, along with the backing Tyvek paper, around an instrument and passed through the open-element incision. ¹ The Tyvek paper is subsequently removed. ¹  The product then expands for tissue coverage following placement through the open-element incision (see video below). ¹

In summary, Seprafilm Adhesion Barrier represents a significant advancement in the reduction of post-surgical adhesions, a common complication in abdominal and pelvic surgeries.² Composed of sodium hyaluronate and carboxymethylcellulose (CMC), Seprafilm Adhesion Barrier is a bioresorbable, transparent film that forms a physical barrier to minimize adhesion formation.¹

Clinical evidence has consistently demonstrated the effectiveness of Seprafilm Adhesion Barrier in reducing adhesion-related complications.^1,6,7 A key aspect of Seprafilm Adhesion Barrier is its versatility and ease of use in various surgical techniques.¹ In hand-assisted, hybrid robotic and laparoscopic procedures, Seprafilm Adhesion Barrier may be a useful adjunct for adhesion prevention.¹ The integration of Seprafilm into these advanced surgical techniques highlights its role in modern surgical practice. By offering a reliable option to a longstanding challenge in surgery, Seprafilm Adhesion Barrier supports patient recovery and exemplifies the progress in surgical adhesion prevention.^1,6,7