orabase and Peritonitis

Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures.. This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test.. Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%).. This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.. ClinicalTrials.gov NCT00813397. Registered 19 December 2008.

Topics: Abscess; Adult; Aged; Carboxymethylcellulose Sodium; Colon; Female; Fistula; France; Humans; Hyaluronic Acid; Laparoscopy; Male; Middle Aged; Peritoneal Diseases; Peritonitis; Powders; Prospective Studies; Rectum; Risk Assessment; Risk Factors; Single-Blind Method; Surgical Wound Infection; Time Factors; Tissue Adhesions; Treatment Outcome

Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed.. This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10) days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10) days and 3 months (+/-14 days) after surgery.. This trial aims to assess, whether the intra-peritoneal application of A-Part Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls.

Topics: Abdomen; Abdominal Wound Closure Techniques; Adult; Biocompatible Materials; Carboxymethylcellulose Sodium; Clinical Protocols; Drug Combinations; Female; Gels; Humans; Male; Peritonitis; Polyvinyl Alcohol; Postoperative Complications; Prospective Studies; Tissue Adhesions; Wound Healing

Postoperative bowel adhesions may lead to various disorders, including abdominal pain, bowel obstruction, ischemia, and necrosis. In previous reports, a dose-dependent increase in bowel adhesions was observed in talc-treated animals in comparison with control animals. Although various methods have been devised to prevent peritoneal adhesions, each of these methods has advantages and disadvantages. In this study, we have attempted to reassess the effect of a carboxymethylcellulose (CMC) solution in the reduction of peritoneal adhesions induced by an intraperitoneal injection of a talc suspension in mice.. Mice received an intraperitoneal injection of a talc suspension, followed by an injection of a CMC solution or vehicle. Two weeks after the injection, any adherent bowel mass was removed en bloc, weighed, and histologically observed.. The administration of talc induced severe bowel adhesions. CMC treatment was unable to completely inhibit the development of bowel adhesions, but treatment did reduce their weight in a dose-dependent manner. According to a histopathologic analysis, the bowel adhesions were composed of a conglomerate of talc aggregate and granulation tissue. The conglomerate was divided into two zones: the cell-rich marginal zone and the cell-scarce central zone. The injection of CMC specifically reduced the width of the marginal zone and the number of infiltrated cells.. This study demonstrated that CMC inhibited bowel adhesions induced by talc in mice. In addition, this is the first report on the effect of CMC on talc peritonitis accompanied by a detailed histologic examination. Our experimental model is very simple and easy to use. Therefore, it may help in the discovery of new antiadhesive agents and in the analysis of the kinetics of bowel adhesion.

Topics: Animals; Carboxymethylcellulose Sodium; Dose-Response Relationship, Drug; Injections, Intraperitoneal; Male; Mice; Mice, Inbred ICR; Peritonitis; Postoperative Complications; Protective Agents; Random Allocation; Talc; Tissue Adhesions; Treatment Outcome

An analysis of complex examination and results of treatment was made in 290 patients with diffuse peritonitis. The patients were divided into two groups according to way of sanation of the abdominal cavity. The sanation with 0.03% aqueous solution of sodium hypochlorite was used for the first group of 155 patients. The immobilized forms of sodium hypochlorite in carboxymethyl cellulose gel were applied in the second group. The rate of postoperative complications was decreased on 15.4%, the lethality--on 8.2% in the case of application of the immobilized forms of sodium hypochlorite. The developed technology allowed increasing of physical component of life quality of the patients in 1.3 times, though it didn't influence on psychical component.

Topics: Abdominal Cavity; Carboxymethylcellulose Sodium; Comparative Effectiveness Research; Disinfectants; Drainage; Drug Carriers; Female; Gels; Humans; Male; Middle Aged; Peritoneal Lavage; Peritonitis; Postoperative Complications; Quality of Life; Severity of Illness Index; Sodium Hypochlorite; Survival Analysis; Tissue Adhesions; Treatment Outcome

Adhesion formation after surgery for peritonitis-related conditions, with such associated complications as intestinal obstruction, pain, and infertility, remains an important problem. Applying a liquid barrier intra-peritoneally might reduce initial adhesion formation.. A combination of the cecal ligation and puncture model of peritonitis with the side-wall defect (SWD) model of adhesion formation was performed. Forty rats were assigned randomly to receive no barrier or 1 mL or 2 mL of the cross-linked polyvinyl alcohol and carboxymethylcellulose (PVA/CMC) hydrogel A-Part(®) Gel (B. Braun Aesculap AG, Tuttlingen, Germany). After 14 days, the animals were sacrificed, and adhesion formation and abscess formation were scored.. Thirty animals survived, distributed equally among the groups. There were significantly fewer adhesions to the SWD in the PVA/CMC groups (median 0) than in the control group (median 26%-50%) (p<0.05). The median tenacity of the adhesions was significantly higher in the control group (Zühlke score 2) than in the PVA/CMC groups (Zühlke score 0) (p<0.05). The amount and size of intra-abdominal abscesses were not significantly different in the three groups.. In this experiment, PVA/CMC hydrogel reduced the amount of adhesions to the SWD and between viscera significantly with equal risk of abscess formation.

Topics: Abdominal Abscess; Animals; Carboxymethylcellulose Sodium; Disease Models, Animal; Male; Peritonitis; Polyvinyl Alcohol; Postoperative Complications; Rats; Rats, Wistar; Tissue Adhesions

Complex examination and the following treatment of 380 patients with diffuse purulent peritonitis were analyzed. The patients were divided into 2 groups. The first group included 245 patients to whom the sanitization of the abdominal cavity used traditional antiseptics. The main group included 135 patients to whom the immobilized form of sodium hypochlorite in the carboxymethyl cellulose was introduced instead of aqueous solution. An original method of sanitization of the abdominal cavity allows 1.2-1.5 times decreased degree of endotoxicosis, 2-2.5 times improved the motor-evacuatory function of the intestine in different forms of treatment of peritonitis. In the main group of patients the number of postoperative complications was 10% less, lethality was 8.2% less.

Topics: Abdominal Cavity; Anti-Infective Agents, Local; APACHE; Carboxymethylcellulose Sodium; Combined Modality Therapy; Drug Carriers; Drug Delivery Systems; Female; Gastrointestinal Motility; Humans; Male; Peritonitis; Postoperative Complications; Sodium Hypochlorite; Suppuration; Surgical Procedures, Operative; Treatment Outcome

56 patients with disseminated purulent peritonitis were observed. All patients were divided into 2 groups. 30 patients treated according to traditional technique formed the first group. Surgical treatment included: laparotomy, elimination of the underlying condition that caused peritonitis, nasointestinal intubation of small intestine, abdominal cavity sanation with 0.02% furacillin solution till pure liquid, drainage. 200 ml of 0.03% aqueous solution of sodium hypochlorite was infused into abdominal cavity before closure. 26 patients treated according to the similar technique formed the second group. In contrast to the first group, 200 ml of immobilized form of sodium hypochlorite in carboxymetilcellulose gel was infused to the patients from the second group before wound closure. In early postoperative period the indices of endotoxicosis were in 1.6 times lower in patients from the second group and motor-evacuatory function of the stomach--twice higher compared with the patients from the first group. It decreased the amount of complications in 2 times, and postoperative lethality--in 2.6 times. In long-term postoperative period perfect treatment results increased in 20.8%, well--in 4.1%, tolerable--decreased in 20.9% compared with the results in the control group.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Disinfectants; Drainage; Drug Combinations; Female; Follow-Up Studies; Gels; Humans; Infusions, Parenteral; Laparotomy; Male; Middle Aged; Peritonitis; Sodium Hypochlorite; Treatment Outcome; Young Adult

To assess whether polysaccharides isolated from fungi, Phellinus spp, could reduce the adhesion and abscess formation in a rat peritonitis model.. Although polysaccharides from Phellinus spp is a well-known material with antiinflammatory properties, little is known regarding its ability to prevent intraperitoneal adhesions. We have assessed the adhesion- and abscess-reducing effect of polysaccharides from Phellinus gilvus (PG) and Phellinus linteus (PL) in a rat peritonitis model.. In 60 SD rats, experimental peritonitis was induced using the cecal ligation and puncture model (CLP). Animals were randomly assigned to 5 groups; ringer lactate solution (RL group), polysaccharides from PG and PL (PG and PL group), hyaluronic acid (HA group), and carboxymethylcellulose (CMC group). Intraperitoneal adhesions and abscesses were noted at 7 day after CLP. RT-PCR assay for urokinase-type plasminogen activator (uPA), its cellular receptor (uPAR), tissue-type plasminogen activator (tPA), plasminogen activator inhibitor type 1 (PAI-1), and tumor necrosis factor (TNF)- alpha was performed to assess the cecal tissue.. Adhesion formation was significantly reduced in PG, PL, CMC, and HA groups (P < 0.001) compared with that in RL group. The incidence of abscesses was also significantly reduced in PG and PL groups (P < 0.05) compared with that in the RL group. The level of uPA, uPAR, tPA, and TNF-alpha was highly expressed in PG and PL group, as compared with the RL group.. We concluded that PG and PL had significant adhesion- and abscess-reducing effects and may act by modulating fibrinolytic capacity of uPA and/or tPA produced from macrophages in a rat peritonitis model.

Topics: Abdominal Abscess; Animals; Ascitic Fluid; Basidiomycota; Carboxymethylcellulose Sodium; Cecum; Hyaluronic Acid; Male; Peritonitis; Plasminogen Activator Inhibitor 1; Polysaccharides; Rats; Rats, Sprague-Dawley; Receptors, Cell Surface; Receptors, Urokinase Plasminogen Activator; Reverse Transcriptase Polymerase Chain Reaction; Tissue Adhesions; Tissue Plasminogen Activator; Tumor Necrosis Factor-alpha; Urokinase-Type Plasminogen Activator

Polysaccharides isolated from fungi, Phellinus spp. is well-known material with anti-tumor and anti-inflammatory properties. We have assessed the adhesion- and abscess-reducing capacity of carboxymethylcellulose (CMC) and polysaccharides from Phellinus spp. combination in a rat peritonitis model. In 72 Sprague-Dawley rats, experimental peritonitis was induced by means of the cecal ligation and puncture model (CLP). After 24 hr, the abdomen was reopened and the ligated cecum was resected. Peritoneal fluid samples were taken for microbiological examination. Rats were randomly assigned to 6 groups: ringer lactate solution (RL group), polysaccharides from Phellinus gilvus (PG group) and Phellinus linteus (PL group), carboxymethylcellulose (CMC group), and their combinations (PG+CMC and PL+CMC groups). Adhesions and abscesses were noted at day 7 after CLP. RT-PCR assay for urokinase-type plasminogen activator (uPA), its cellular receptor (uPAR), and tumor necrosis factor (TNF)-alpha was performed to assess the cecal tissue. Microbiological examination showed polymicrobial bacterial peritonitis. Adhesion formation was significantly reduced in PG+CMC and PL+CMC groups (P<0.05). The incidence of abscesses was reduced in all treated groups except the RL group (P<0.05). uPA, uPAR, and TNF-alpha mRNA were highly expressed in the PG+CMC and PL+CMC groups, as compared to the RL group. We concluded that the combination of polysaccharides and CMC had significant adhesion- and abscess-reducing effects compared with their single treatment and the effects may act by modifying the fibrinolytic capacity of uPA, uPAR and TNF-alpha produced from activated macrophages in a rat peritonitis model.

Topics: Abscess; Animals; Basidiomycota; Carboxymethylcellulose Sodium; Cecum; DNA Primers; Drug Therapy, Combination; Male; Peritonitis; Polysaccharides; Rats; Rats, Sprague-Dawley; Receptors, Cell Surface; Receptors, Urokinase Plasminogen Activator; Reverse Transcriptase Polymerase Chain Reaction; Tissue Adhesions; Tumor Necrosis Factor-alpha; Urokinase-Type Plasminogen Activator

Intra-abdominal infection is complicated by adhesion and abscess formation. We have assessed the adhesion- and abscess-reducing capacity of various solution volumes and concentrations of two polyanionic polysaccharides, hyaluronan (HA) and carboxymethylcellulose (CMC), in a rat peritonitis model.. In 192 male Wistar rats a bacterial peritonitis was induced using cecal ligation and puncture. After 24 h the abdomen was reopened and the ligated cecum resected. Animals were randomized into three control groups, nine groups treated with various solution volumes (1 to 8 ml) containing different HA concentrations, and four groups treated with 1.7% CMC solution. Rats were killed at day 7, postoperatively, and adhesions were scored at five abdominal sites on a scale from 0 to 4. The presence and size of intra-abdominal abscesses were noted.. Fifty-four rats (28%) prematurely died. There was no significant difference in mortality between treatment groups and controls. Treatment with CMC (P < 0.001) and low (0.2 and 0.4%) concentrations of HA (P < 0.005) significantly reduced intra-abdominal adhesion formation. High volumes of 0.2 and 0.4% HA were most effective (P = 0.01). The effect of CMC was volume independent. The incidence of abdominal abscesses was also significantly reduced by treatment with either CMC (P < 0.001) or low concentrations of HA (P < 0.001). With regard to abscess formation the effect was independent of the volume administered for HA, while low volumes of CMC were most effective (P < 0.005).. Intraperitoneal treatment with either CMC or low-viscosity HA solution reduced intra-abdominal adhesion and abscess formation in a rat peritonitis model. The volume-induced reduction in adhesion formation suggests a hydroflotation effect of HA solution.

Topics: Abscess; Animals; Carboxymethylcellulose Sodium; Disease Models, Animal; Hyaluronic Acid; Male; Peritonitis; Rats; Rats, Wistar; Tissue Adhesions

To assess the efficacy of Oxiplex (FzioMed, Inc., San Luis Obispo, CA) barriers.. Film of polyethylene oxide and carboxymethylcellulose (Oxiplex) were tested for strength and tissue adherence. Films were selected for evaluation in models for biocompatability and adherence. Three films were selected for evaluation in efficacy studies, and one was evaluated for effects on bacterial peritonitis. Handling characteristics of Oxiplex film were evaluated via laparoscopy.. University laboratory.. Rabbits, rats, pigs.. Placement of Oxiplex prototypes at the site of injury.. Mechanical properties, biocompatibility, tissue adherence, adhesion development, infection potentiation, and device handling.. Mechanical tests indicated that tensile strength and elongation were inversely correlated. All films tested had excellent tissue adherence properties. Selected films, based on residence time and biocompatibility, prevented adhesion formation in all animals and were highly efficacious in preventing adhesion reformation. The optimal Oxiplex prototype prevented adhesion reformation in 91% of the animals. This Oxiplex film, dyed to allow visualization, prevented adhesion reformation and did not affect bacterial peritonitis. In a laparoscopic model, the Oxiplex film, delivered in FilmSert forceps, via a 5.0-mm trocar, rapidly unfurled and could be easily applied to tissue with strong adherence.. These data show development of an adhesion prevention material that is tissue adherent, can be placed via laparoscopy, and does not affect host resistance.

Topics: Absorbable Implants; Animals; Biocompatible Materials; Carboxymethylcellulose Sodium; Cellulose; Disease Models, Animal; Female; Laparoscopy; Materials Testing; Peritonitis; Polyethylene Glycols; Rabbits; Rats; Rats, Sprague-Dawley; Stress, Mechanical; Surgical Wound Infection; Swine; Tissue Adhesions