Hemopatch® as a sealant in anastomotic and suture leak prevention in abdominal emergency surgery: A single-center case series

Abstract

BACKGROUND

Anastomotic and suture leakage remain major causes of morbidity and mortality in emergency abdominal surgery, particularly in patients with peritonitis, sepsis, or poor nutritional status. Hemopatch^® is a collagen-based hemostatic pad with sealing properties that has been widely used in elective surgical settings, but evidence in emergency abdominal surgery is limited.

AIM

To evaluate the safety and effectiveness of Hemopatch^® as a reinforcement sealant for sutures and anastomoses in emergency abdominal surgery.

METHODS

We conducted a single-center retrospective case series including 36 consecutive patients who underwent emergency abdominal surgery between July 2021 and September 2022. Hemopatch^® was used in 14 bowel anastomoses, 22 suture reinforcements (including appendiceal, gastric, pancreatic, splenic, gallbladder, and rectal stump closures), and one pancreaticojejunostomy.

RESULTS

Four of 36 patients (11.1%) developed postoperative complications related to leakage: one bowel anastomotic leak, two suture dehiscences, and one biliary fistula. Two deaths occurred in elderly patients with severe comorbidities and septic conditions. No device-related adverse events, allergic reactions, or surgical site infections attributable to Hemopatch^® were observed.

CONCLUSION

Hemopatch^® seems safe for reinforcing sutures and anastomoses in emergency abdominal surgery. Its effectiveness may be reduced in advanced chemical peritonitis or diffuse septic conditions. Larger controlled studies are needed to confirm these findings.

Key Words: Sealant; Anastomosis; Emergency surgery; Leak; Prevention; Case series

Core Tip: Emergency abdominal surgery carries a high risk of anastomotic and suture failure, particularly in septic or malnourished patients. In this single-center case series of 36 emergency procedures, Hemopatch^® was used as an adjunct sealant for anastomoses and sutures, with an overall leakage rate of 11.1% and no device-related complications. Although limited by the absence of a control group, these findings suggest that Hemopatch^® may represent a useful reinforcement tool in selected high-risk emergency settings.

INTRODUCTION

Anastomotic leakage and suture dehiscence are among the most feared complications in emergency abdominal surgery, contributing significantly to postoperative morbidity and mortality. In contrast to elective surgery, emergency procedures are frequently performed in the setting of peritonitis, sepsis, tissue edema, and impaired nutritional or metabolic status; all of which negatively affect tissue healing[1].

Hemopatch^® (Baxter Healthcare Corporation, Deerfield, IL, USA) is a collagen-based hemostatic pad coated with a reactive polyethylene glycol [N-hydroxysuccinimide-functionalized polyethylene glycol (NHS-PEG)] layer that promotes tissue sealing upon contact with body fluids. Its hemostatic efficacy has been extensively reported[2,3], and its sealing properties have been described in neurosurgery[4,5], cardiac surgery[6], thoracic surgery[7], and hepatopancreatobiliary procedures[8,9]. However, data regarding its use as a sealant in emergency abdominal surgery remain scarce. This study reports our single-center experience using Hemopatch^® as a reinforcement for sutures and anastomoses in emergency abdominal surgery.

MATERIALS AND METHODS

A comprehensive review of the literature was conducted using the keyword “Hemopatch” in PubMed and major surgical databases to identify clinical reports on the use of Hemopatch^® as a sealant in elective and emergency surgical settings. This study was conducted in accordance with the Declaration of Helsinki. Ethical committee approval was not required because Hemopatch^® is an approved medical device used within standard surgical practice and no experimental intervention was performed. Written informed consent for treatment and data use was obtained from all patients prior to surgery.

RESULTS

This was a single-center retrospective case series including patients who underwent emergency abdominal surgery between July 2021 and September 2022. We included 36 patients operated on by a single surgeon in emergency conditions. The cohort consisted of 27 males and nine females, with a mean age of 58 years (range: 19-91 years) (Table 1). Hemopatch^® was applied according to the manufacturer’s instructions. Hemopatch^® is a collagen-based sealing hemostatic patch coated with NHS-PEG, which forms a hydrogel upon contact with body fluids, promoting tissue sealing[2]. The collagen pad was positioned over the suture or anastomosis to be reinforced and activated with a few drops of sodium bicarbonate solution to promote adhesion (Figure 1)[2].

Figure 1 Intraoperative application of Hemopatch^® during manual bowel anastomosis. A: Completed hand-sewn bowel anastomosis; B: Placement of Hemopatch^® over the anastomotic line to reinforce the suture; C: Activation of the sealing layer using sodium bicarbonate solution; D: Final adherence of the hydrated Hemopatch^® to the anastomosis.

Table 1 Patients’ features, mean (interquartile rage)/n (%).

Variable	Value
Total patients	36
Age (yr)	58 (19-91)
Male	27 (75)
Female	9 (25)
Mean follow-up (mo)	3.5
Peritonitis present	28 (78)

We used it as a reinforcement in 14 bowel anastomoses (five ileum and nine colon), six appendiceal stump closures, seven peptic ulcer sutures (Figure 2), three gallbladder stump closure after subtotal cholecystectomy (Figure 3), one splenic suture, two pancreatic tail sutures, one pancreaticojejunostomy, and two peritoneal defect replacements.

Figure 2 Surgical management of perforated gastric ulcer with reinforcement using Hemopatch^®. A: Intraoperative view of a perforated gastric ulcer; B: Primary closure of the perforation with interrupted sutures; C: Application of Hemopatch^® over the suture line to reinforce the repair and provide additional sealing.

Figure 3 Reinforcement of the infundibular stump after subtotal cholecystectomy using Hemopatch^®. A: Infundibular stump following subtotal cholecystectomy for severe cholecystitis; B: Suture closure of the infundibular region; C: Placement of Hemopatch^® over the suture line to reinforce the closure and reduce the risk of bile leakage.

Patients underwent clinical postoperative follow-up, with radiological assessment (computed tomography) when clinically indicated. The primary outcome was the occurrence of postoperative leakage or dehiscence. Secondary outcomes included fistula formation, need for reintervention, mortality, and device-related adverse events.

Thirty-two of 36 patients (88.9%) showed an uncomplicated postoperative course. Among 14 patients with bowel anastomoses, one (7.1%) developed an anastomotic leak. This occurred in a 75-year-old male who underwent left colectomy with a tensioned anastomosis. Among 22 reinforced sutures, two with dehiscence (9.1%) were observed: One gastric perforation in advanced chemical peritonitis and one rectal stump in an older patient with severe dysproteinemia and anemia.

One biliary fistula developed after subtotal cholecystectomy in a patient with gangrenous cholecystitis and diffuse peritonitis. The fistula was managed with fasting and parenteral nutrition. Two deaths occurred. An 89-year-old male with rectal stump dehiscence died after 9 days of cardiopulmonary failure, and a 78-year-old female with biliary fistula died, despite surgical recovery, at postoperative day 39 due to mycotic sepsis. Hemopatch^® was left in situ during every intervention and no seromas, allergic reactions, surgical site infections, or complications directly attributable to it were observed. Mean follow-up was 3.5 months (range: 3 weeks to 12 months). Patients’ procedures and outcomes are summarized in Table 2.

Table 2 Patients’ procedures and outcomes, n (%).

Procedure type	No. of cases	Leakage/failure	Mortality
Bowel anastomosis	14	1 (7.1)	0
Gastric suture	7	1 (14.3)	0
Rectal stump	1	1 (100)	1
Appendiceal stump	6	0	0
Gallbladder stump	3	1 (33.3)	1
Pancreatic suture/PJ	3	0	0
Splenic suture	1	0	0
Peritoneal defect repair	1	0	0
Total	36	4 (11.1)	2 (5.6)

PJ: Pancreaticojejunostomy.

DISCUSSION

Anastomotic leakage remains a major determinant of postoperative morbidity and mortality in gastrointestinal surgery, particularly in high-risk settings. In elective colorectal surgery, reported leakage rates range between 3% and 8%[1]. In emergency settings rates may rise to 10%-20%, particularly in the presence of peritonitis, hemodynamic instability, malnutrition, or advanced age[1]. Similarly, gastric suture failure in perforated peptic ulcer has been reported in 4%-16% of cases, depending on septic burden and timing of intervention[10]. In the present series, the overall leakage-related complication rate was 11.1%, which falls within the range reported in emergency gastrointestinal surgery. Although direct statistical comparison is not possible due to the absence of a control group, this rate appears comparable to those reported in the literature for similar high-risk settings. Beyond technical precision, increasing attention has been directed toward adjunctive strategies aimed at reinforcing anastomotic integrity and improving tissue sealing. Among these, external coating or sealing of the anastomotic line with collagen- or fibrin-based materials has emerged as a promising approach in reducing peritoneal contamination and enhancing anastomotic resistance[11,12]. Hemopatch^® is a hemostatic biocompatible sponge with sealant properties. It is composed of a pliable collagen pad that induces platelet aggregation. It is covered on one side by an NHS-PEG layer which can form a hydrogel when in contact with body fluids and guarantees the sealing of the tissue of interest[2]; on the other side, the brilliant blue squares indicate the nonadhesive side of the device. In the literature, many studies have been conducted on the hemostatic properties of Hemopatch^® on almost every bleeding surface[13], including in patients with thrombin- or platelet-induced coagulopathy[2]. However, fewer studies have investigated the sealant features of this device. Studies investigating this peculiarity have been conducted mainly in the fields of neurosurgery[4,5], cardiac surgery[6] and hepatobiliary surgery, especially for preventing postoperative pancreatic fistula[8,9]. According to our literature search, there are still no reports on the role of Hemopatch^® as a sealant in emergency abdominal surgery. Emergency abdominal surgery represents one of the highest-risk scenarios for anastomotic failure due to factors such as peritonitis, tissue edema, systemic inflammation, and metabolic derangements. In this context, adjunctive reinforcement with a collagen-based sealant may offer additional mechanical support and contribute to improved anastomotic stability, although its effectiveness may still be limited in the presence of advanced septic or diffuse inflammatory conditions. The theoretical rationale for using a collagen-based sealing patch lies in its ability to provide both mechanical reinforcement and tissue sealing at the suture or anastomotic line. The NHS-PEG reactive layer forms a hydrogel upon contact with body fluids, creating a physical barrier that may help limit microleakage and local contamination during the early phases of tissue healing[2].

Different classes of sealants have been investigated as adjuncts to reduce anastomotic leakage, including fibrin-based adhesives, synthetic polyethylene glycol hydrogels, and cyanoacrylates. However, these materials present important biological and mechanical limitations. Fibrin sealants, although widely used, are rapidly degraded in the gastrointestinal environment and may not provide sufficient mechanical strength under conditions of tension or inflammation. Experimental studies have even suggested that fibrin-based coatings do not improve anastomotic healing and may reduce bursting pressure compared to standard sutures[14]. Similarly, PEG-based sealants form hydrogels through polymer crosslinking but may undergo significant postoperative swelling, potentially leading to tissue compression or mass effect. In addition, their purely synthetic structure lacks a biological scaffold capable of supporting tissue integration, and current evidence does not consistently demonstrate a reduction in anastomotic leakage rates[15]. Cyanoacrylates and other synthetic adhesives may provide rapid sealing but have been associated with local toxicity, foreign-body reactions, and mechanical mismatch with intestinal tissue[2,15]. In contrast, Hemopatch^® combines a collagen matrix with a reactive NHS-PEG layer, providing both a biological scaffold and a rapid sealing mechanism. The collagen structure may promote tissue integration and fluid absorption, while the PEG component forms a stable hydrogel that adheres to the tissue surface. Importantly, the collagen backing limits excessive swelling, potentially reducing the risk of compression-related complications compared with purely synthetic hydrogels[2]. This dual mechanism may represent a more physiologically compatible approach for reinforcing gastrointestinal sutures and anastomoses, particularly in high-risk conditions such as inflammation, edema, or sepsis.

We evaluated the efficacy of Hemopatch^® as a sealant in different scenarios, in which the device was applied in a variety of sutures and anastomoses and in patients with different pathology, clinical status, and comorbidity. We retrospectively analyzed 36 patients operated on by a single surgeon in emergency settings, in which Hemopatch^® was used as a reinforcement for sutures or anastomoses in critical conditions. Four leakage-related complications were observed in our series. The clinical context of these cases highlights the complex conditions frequently encountered in emergency abdominal surgery. Anastomotic dehiscence occurred in a 75-year-old male patient who underwent left colectomy with a tensioned anastomosis. Rectal stump dehiscence developed in an 89-year-old male who presented to the emergency department with a strangulated left inguinal hernia and severe dysproteinemia. Bowel necrosis involved the upper rectum, requiring anterior rectal resection and Hartmann procedure. Hemopatch^® was applied to reinforce the rectal stump suture (Figure 4). The severe nutritional impairment and anemia likely contributed to stump dehiscence. Gastric suture dehiscence occurred in a 58-year-old male with advanced chemical peritonitis due to a perforated gastric ulcer. The perforation was initially sutured and reinforced with Hemopatch^®. One week later, the patient required reoperation due to suture failure, and a distal gastric resection was performed without further complications. A biliary fistula developed in a 91-year-old female who underwent open subtotal cholecystectomy for gangrenous perforated cholecystitis with diffuse peritonitis and multiple hepatic abscesses. Hemopatch^® was applied to reinforce the sutured infundibular stump. Due to the severe purulent peritonitis, the cystic duct closure failed, resulting in bile leakage that was successfully managed with endoscopic biliary stenting. The patient recovered from a surgical standpoint but died 1 month later due to pulmonary complications.

Figure 4 Reinforcement of the rectal stump after anterior rectal resection. The rectal stump is covered with Hemopatch^® to protect the suture line and potentially reduce the risk of postoperative leakage (white arrow).

This paper shows several limitations. Firstly, the limited number of patients. Only the application of Hemopatch^® under emergency conditions was analyzed. Additionally, we did not have a control group, therefore more studies are needed to obtain a higher level of evidence. Another limitation of the study was the variety of indications and surgeries. Even though they were all associated with peritonitis or an advanced inflammatory state, the perspective should be that of conducting single studies comparing the groups of patients for each surgical indication separately, as the incidence of suture and anastomoses dehiscence varies between surgical sites.

CONCLUSION

Anastomotic and suture failure remain major sources of morbidity and mortality in emergency abdominal surgery, where adverse local and systemic conditions frequently compromise tissue healing. In this single-center case series, the use of Hemopatch^® as an adjunctive reinforcement for sutures and anastomoses was associated with an acceptable rate of leakage-related complications and no device-related adverse events, despite the high-risk clinical context.

Hemopatch^® represents a feasible adjunct rather than a substitute for meticulous surgical technique and sound clinical judgment. Further prospective, controlled studies are required to define its precise role, optimal indications, and potential benefits in emergency surgery. Until such evidence is available, Hemopatch^® should be considered a complementary tool in carefully selected cases, particularly when local tissue conditions are suboptimal but not irreversibly impaired.