Interceed Group Research Articles

To Investigate the Effectiveness of Systemic Tropisetron Use and Intra-Abdominal Adhesion Barrier in Preventing Postoperative Pelvic Adhesions in a Rat Model

Aim: Postoperative pelvic adhesions remain a significant challenge in gynecological and general surgeries, leading to considerable morbidity, including chronic pelvic pain, infertility, and bowel obstruction. Preventing the formation of postoperative adhesions is paramount in reducing associated morbidity. The aim of this study is to investigate preventive measures and advanced treatment interventions for postoperative pelvic adhesions. Methods: In this study, 40 female Albino Wistar rats, each weighing between 200-250 grams and aged three months, were utilized. Three experimental groups and one control group were formed, each consisting of 10 rats. Intraperitoneal administration of 10 mg/kg xylazine and 50 mg/kg ketamine hydrochloride was used as the anesthesia method for all rats. After a five-day treatment period, the adhesions observed in the abdomen were examined microscopically and scored. The hydroxyproline levels after the five-day treatment period were examined in the groups. Results: Adhesions were scored in the groups. The results of the intergroup comparisons related to the scoring. Accordingly, the highest score was observed in the control group, while the lowest score was detected in the Interceed group. Based on the histological scoring results, it was determined that scores of 3 and 4 were less frequent, while a score of 0 was more frequent in the amnion membrane and Interceed groups. Hydroxyproline levels were lower in the amnion membrane and Interceed groups, while they were higher in the control and tropisetron groups. Conclusion: While significant progress has been made in preventing postoperative pelvic adhesions, challenges remain in translating these advances into consistent clinical outcomes.

New Use of an Absorbable Adhesion Barrier (INTERCEED) for Temporary Diverting Ileostomy in Minimally Invasive Rectal Surgery

Abstract Objectives Sometimes, severe adhesion occurs between the rectus abdominis muscle and the ileal intestinal limbs after temporary diverting ileostomy. This can make ileostomy reversal difficult. The aim of the present study is to assess whether absorbable adhesion barrier made of oxidized regenerated cellulose (INTERCEED) could contribute to improved surgical outcomes in stoma reversal. Methods This was a single-institutional retrospective study. A total of 36 consecutive patients who underwent ileostomy reversal by a single surgeon were retrospectively reviewed. INTERCEED was inserted between the ileal limbs and the rectus abdominis muscle at the time of ileostomy creation in 12 patients. Surgical outcomes of the ileostomy reversal were compared between patients treated with and without INTERCEED. Results The degree of adhesion formation between the ileal limbs and the rectus abdominis muscles, operating time, and estimated blood loss were significantly reduced in patients treated with INTERCEED compared with those treated by the conventional approach. None of the patients in the INTERCEED group had postoperative complications after the initial surgery and ileostomy reversal. Conclusions INTERCEED is suitable for insertion between the ileal limbs and the rectus abdominis muscles because of its softness and flexibility. The use of INTERCEED for diverting ileostomy contributes to reduced adhesion formation, operative time, and blood loss in patients, and further research is needed to confirm our results.

Safety of Use of a Sheet-Type Adhesion Barrier (Interceed®) During Liver Surgery.

Adhesion barriers are increasingly used in hepatobiliary surgery. However, there has been no solid evidence yet in support of their safety. Incidences of global postoperative morbidities and major abdominal morbidities were compared between 101 consecutive patients who received a sheet-type adhesion barrier (Interceed®) and 134 patients who did not receive any adhesion barriers during hepatectomy. Propensity score (PS) adjustment was used to account for potential bias to receive Interceed. In the PS-adjusted population, the incidences of both global postoperative morbidities and major abdominal morbidities showed no significant difference between the Interceed group and the control group (17.9% vs. 17.6%; P = 0.948 and 7.8% vs. 9.1%; P = 0.813, respectively). Multivariate analysis showed that age + 10years (odds ratio [OR], 1.70; 95% CI, 1.15-2.50; P = 0.007), estimated blood loss + 100mL (OR, 1.05; 95% CI, 1.01-1.09, P = 0.009), and laparoscopic approach (OR, 0.10; 95% CI, 0.01-0.75; P = 0.026) were independent predictors for global postoperative morbidities and operation time + 1h (OR, 1.56; 95% CI, 1.23-1.96; P < 0.001) was a risk factor for major abdominal morbidity, while no specific association between the use of Interceed and the risk of postoperative morbidity was observed. Use of Interceed does not increase the risk of postoperative morbidities after hepatectomy.

1469 Comparison of Neovaginoplasty Using Acellular Porcine Small Intestinal Submucosa Graft or Interceed in Patients with Mayer-Rokitansky-Küster-Hauser Syndrome

Study Objective To compare using the acellular porcine small intestinal submucosa (SIS) graft or the Interceed in patients with MRKH syndrome undergoing creation of a neovagina. Design Retrospective study. Setting Academic affiliated community hospital. Patients or Participants Patients with MRKH syndrome undergoing creation of a neovagina from 2016 to 2018 were retrospectively investigated. Interventions Wharton-Sheares-George neovaginoplasty was performed using the acellular porcine small intestinal submucosa (SIS) graft or the Interceed. Measurements and Main Results Overall 67 patients were included (24 for the SIS graft, 43 for the Interceed) for analysis. The operating time, the estimated blood loss and return of bowel activity in the SIS graft group were similar with that in the Interceed group. However, the total cost in the SIS group was significantly higher than that in the Interceed group due to the cost of the SIS graft ($2570 per graft). All patients had a continuous mold wearing time for 6 months postoperatively and then returned for their follow-up. The mean length and width of the neovagina in the SIS graft group were similar with the Interceed group (7.0±0.6 cm vs 7.1±0.8 cm, P=.54, 2.8±0.3 cm vs 2.7±0.5 cm, P=.74, respectively). However, the incidence of granulation at the vaginal apex was higher in the SIS graft group than that in the Interceed group (6/24 vs 4/43, p Conclusion Our results demonstrated that Wharton-Sheares-George provided the patients to have satisfactory sexual intercourse. The Interceed played a role in the reconstruction of neovagina no less than the SIS graft.

The Prevention of Hepatectomy-Induced Adhesions by Bilayer Sponge Composed of Ultrapure Alginate

BackgroundAdhesion formation is a critical issue in surgery, particularly in hepatectomy. The present study aimed to develop a bilayer adhesion barrier comprising alginate (Alg) of different molecular weight (Mw). It was expected that a slowly dissolving layer remains on the cut surface, functioning as a physical barrier, whereas a rapidly dissolving layer widely distributes in the peritoneal cavity to prevent de novo adhesions. MethodsBilayer Alg sponges were fabricated using low Mw Alg for the upper layer and high Mw Alg for the bottom layer. The dissolution behavior of each layer was evaluated in vitro in peritoneum-like environments. We constructed a Pean crush hepatectomy-induced adhesion model in rats. The effects of the bilayer sponge on cut surface and de novo adhesions were separately evaluated in terms of their extent and grade. ResultsThe Alg sponge layer with low Mw dissolved faster than that with high Mw in vitro. One week after the hepatectomy, although no significant decrease in adhesion extent on the cut surface was observed in rats that received Seprafilm and Interceed, treatment with Alg bilayer sponge significantly decreased the adhesion extent to 38% of that without treatment. Moreover, a significant decrease in de novo adhesion extent was observed in the Alg bilayer sponge compared with the Interceed group. ConclusionsThe Alg bilayer sponge was effective for preventing both cut surface and de novo adhesions in the rat Pean crush hepatectomy model. The simple yet functional design of the Alg bilayer sponge can facilitate its use in future clinical practice.

Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P=0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe.

Antiadhesive effect and safety of oxidized regenerated cellulose after thyroidectomy: a prospective, randomized controlled study

PurposeTo evaluate the antiadhesive effects and safety of an oxidized regenerated cellulose (Interceed) after thyroidectomy.MethodsSeventy-six thyroidectomized patients were prospectively randomized into two groups with regard to the use of Interceed. We evaluated each group for their adhesive symptoms using four subjective and four objective items at the 2nd week, 3rd and 6th month after thyroidectomy. All patients were examined for vocal cord motility by indirect laryngoscope at each period.ResultsTotal adhesion scores at each postoperative follow-up period decreased with time, but were not significantly different in each group. The median score for swallowing discomfort for liquid was significantly lower in the Interceed group than in the control group 2 weeks after surgery. In addition, the severity of skin adhesion to the trachea was reduced in the Interceed group compared with the control group 6 months after surgery. During the study, there were no adverse effects or significant differences in postoperative complications between the groups.ConclusionInterceed appeared to be safe and effective in improving neck discomfort at early postoperative periods and preventing skin adhesion to the trachea 6 months after thyroidectomy.

Barrier methods used to prevent pelvic adhesions in videolaparoscopy: experimental study in female rabbits

This study was designed to evaluate the effectiveness of barrier methods to prevent adhesions in videolaparoscopy, comparing the use of Surgicel(®) and Interceed(®) with the control group. We performed a controlled, randomized study in healthy adult female rabbits Oryctolagus cuniculu, inducing adhesions in the abdominal wall by resection of a peritoneal fragment and cauterization. In the control group, surgery was performed, and the other group was randomized to the use of the barrier method. After 21 days, videolaparoscopy was repeated, and the presence or absence of adhesions and their score were verified by performing biopsies of the surgical site in all groups. No statistical differences were found in the results on adhesion formation and adhesions score among the three groups. In the control group, there were 54.5% cases of adhesion formation; the median score of adhesions was 6 (range, 3-10). In the Surgicel(®) group, there were 45.5% cases of adhesion formation; median score of adhesions was 6 (range, 4-10). In the Interceed(®) group, there were 45.5% cases of adhesion formation; median score of adhesions was 5 (range, 3-11). No difference was found using barrier methods, Surgicel(®), and Interceed(®) for preventing adhesion formation in videolaparoscopy.

The effect of Interceed for reducing adhesion as a middle ear packing agent: An experimental study

Interceed (oxidized regenerated cellulose) has been used to prevent postoperative abdominal adhesion. However, the efficacy and safety of using Interceed in middle ear surgery have not been thoroughly studied. The animals were divided into two groups: the Interceed group and the Gelfoam (Gelatin sponge) group. In every group, the study was performed on five guinea pigs (ten ears). Under the aseptic condition, the middle ear mucosa was abraded using a pick through a myringotomy incision. Interceed and Gelfoam were then packed into the guinea pigs' middle ear cavities. The auditory brainstem responses (ABRs) were assessed preoperatively and at 3 weeks after the operation with the animals under general anesthesia. Histopathologic study was performed 3 weeks after the operation. The ABR results on postoperative week 3 showed no statistically significant difference for myringotomy and postpacking. The fibrosis, middle ear mucosa thickening and adhesion formation appeared to be less in the Interceed group compared with the Gelfoam group. Any foreign body reaction was not observed in the Interceed group. Our results show that Interceed is nonototoxic and biocompatible with the guinea pig's middle ear cavity. Therefore, these results suggest that Interceed could be used safely in the middle ear as a middle ear packing agent during otosurgery.

Cross-linked poly (gamma-glutamic acid) attenuates peritoneal adhesion in a rat model

Poly (gamma-glutamic acid) (PGA) is a naturally occurring biodegradable polymer produced by Bacillus subtilis. PGA is crosslinked by gamma-irradiation to yield crosslinked PGA (XL). XL absorbs large amounts of fluid and forms a biodegradable viscous hydrogel. In the present study, we evaluated the anti-adhesive effect of XL in a rat abdominal wall defect and cecal abrasion model. Abdominal wall resection and cecal abrasion were carried out in rats (abrasion-no-treatment group, n = 12). In the treatment groups, the following materials were applied: PGA (n = 12), XL (n = 16), hyaluronic acid (HA) (n = 12), Seprafilm (n = 12), and Interceed (n = 10). A week later, adhesion formation was evaluated. Firm adhesions were seen in the abrasion-no-treatment group. XL reduced adhesion formation significantly compared with abrasion-no-treatment, HA, Seprafilm, and Interceed groups. Although not statistically significant, the magnitude of adhesion formation was decreased in the XL group in comparison to the PGA group. We suggest that the anti-adhesive effect of XL was superior to other materials in this rat model. XL application may have attenuated tissue adhesion by forming a viscous hydrogel over the injured surfaces.

O-192: Interceed® vs double layer Surgicell® for prevention of adhesion formation in the rabbit model

Post operative adhesions cause significant morbidity related to small bowel obstruction, chronic pelvic pain and infertility. Interceed, an adhesion barrier composed of oxidized regenerated cellulose (ORC) is shown to decrease adhesion formation significantly in randomized controlled studies, but the cost of the product prevents its widespread use. Surgicell, another product composed of ORC, but marketed as a haemostatic agent, costs approximately 90% less than Interceed. The main difference between two products is Interceed being approximately twice more densely knitted and having smaller pores than Surgicell. Therefore we hypothesized that double layer Surgicell could be as effective as single layer Interceed for preventing adhesions. This study was designed to compare two products in terms of reduction of adhesion formation in the rabbit model. Prospective, randomized, controlled, single blind study. 26 New Zealand White female rabbits of reproductive age were included in the study. Following appropriate anesthesia a midline laparotomy was performed and the ovaries were bivalved with a scalpel. Hemostasis was provided with microbipolar cautery. One of the ovaries was assigned to be covered by a single layer of Interceed® measuring 2cm X 1cm, while the other was assigned to be covered by double layer of Surgicell® of the same size, according to a computer generated randomization table. After the placement, the adhesion barriers were moistened with two drops of sterile normal saline to have them adhered to the ovarian surface. Four weeks later a second look laparotomy was performed and the adhesions were macroscopically scored by an investigator who was blinded to the barrier assignment of the ovaries. Adhesions were scored on a scale of 1 to 4: 1 = no adhesions; 2 = minimal filmy adhesions that were easily separable; 3 = dense adhesions limited to the adnexal area; 4 = extensive dense adhesions, and adhesions of viscera to anterior or posterior abdominal wall. Distribution of adhesions among the groups was compared with chi-square test. 26.9% of the ovaries in both groups had no macroscopic adhesions. While 42.3% of the ovaries in the Interceed group had filmy adhesions that were easily lysed 38.5% of group 2 had adhesions of the same type (p=0.77). Dense adhesions, limited to the adnexal area were present in 19.2% and 26.9% of group1 and group 2 respectively (p=0.51). Widespread adhesion were observed in 11.5% of group 1 and 7.7% of group 2 (p=1). The distribution of adhesions was similar in two groups (Table).Tabled 1 Our results demonstrate that Surgicell, when applied as double layer, is as effective as Interceed in reducing postoperative adhesion formation in the rabbit model. Provided that these results are confirmed in humans the application of Surgicell as an adhesion barrier may be more cost effective.

A novel hyaluronan-based gel in laparoscopic adhesion prevention: preclinical evaluation in an animal model

Objective: To evaluate the effectiveness of a crosslinked hyaluronan solution (ACP gel) in the prevention of postsurgical adhesions in laparoscopic surgery. Design: A randomized blinded study using a rabbit model in laparoscopic surgery. Setting: A standardized surgical trauma in the rabbit uterine horn to induce adhesion formation. Animals: Sixty-four sexually matured female New Zealand white rabbits weighing 2.5 to 3.0 kg and aged 3–4 months. Intervention(s): After trauma, group 1 (n = 22) received no treatment, group 2 animals (n = 20) received oxidized-regenerated cellulose (Interceed [TC71), in group 3 (n = 22) 5 mL of ACP gel were applied on the lesion. Main Outcome Measure(s): Six weeks after laparoscopy, a laparotomy was performed and the adhesions were scored according to Blauer's scoring system. Result(s): 66% of the untreated animals and 85% of the animals treated with Interceed presented with severe adhesions, whereas only 35% of the ACP gel treatment group had significant adhesions. The mean (± SEM) increased adhesion score was 2.24 ± 0.26 in the untreated group, 2.45 ±0.22 in the Interceed group, and was 1.25 ± 0.28 in the ACP gel group. Conclusion(s): This study revealed that ACP gel holds promise as a novel resorbable biomaterial for the reduction of postoperative adhesions after laparoscopic surgery.

Effects of Ringer’s lactate, lnterceed(TC7) and Gore-Tex Surgical Membrane on postsurgical adhesion formation

To evaluate the effects of Ringer’s lactate instillation, Interceed(TC7) (Johnson and Johnson Medical, Inc., New Brunswick, NJ), and Gore-Tex Surgical Membrane (W. L. Gore and Associates, Inc., Flagstaff, AZ) in a rat uterine horn model. Rats were in a conventional laboratory setting. Sprague-Dawley white rats, weighing 225 to 250 g. The left uterine horn was subjected to a standardized lesion by serosal denudation and devascularization. The rats were randomly assigned into control group, Interceed(TC7) group, Gore-Tex group, and Ringer’s lactate group. Degree of adhesions was evaluated 2 weeks after the initial surgery. Adhesion score after Ringer’s lactate instillation was significantly lower than those of control, Interceed(TC7), and Gore-Tex groups. Gore-Tex was associated with less adhesion formation than control. No difference was found in the adhesion formation between the Interceed(TC7) group and the control group. Confirming our previous observations, Ringer’s lactate instillation is effective in decreasing adhesion formation. Gore-Tex reduces adhesion formation, but its efficacy is inferior to those of Ringer’s lactate. Contrary to previous reports, Interceed(TC7) is ineffective in our animal model.