Pre-clinical evaluation of a next-generation spray adhesion barrier for multiple site adhesion protection.

Intra-abdominal adhesions represent a major cause of postoperative morbidity, including chronic or recurrent pelvic pain and infertility in a significant percent of patients. The SprayShield™ Adhesion Barrier System (Covidien, Waltham, MA) is a next-generation sprayable adhesion barrier to prevent postoperative adhesions. Initially sprayed as a liquid, SprayShield™ solidifies within 2 seconds of contact with tissue through a polyethylene glycol (PEG) ester-Trilysine reaction to form an adherent, internal tissue barrier that protects the underlying tissues for several days after surgery. After tissue begins to heal, the adhesion barrier liquefies via hydrolysis and completely absorbs within 7 days. Safety testing has shown the product to be nongenotoxic, noncytotoxic, nonsensitizing, and nonirritating. SprayShield™ has been shown to adhere well to tissue, with the mechanism of adherence believed to be mainly due to tissue surface mechanical interlocking. In studies that compared SprayShield™ to good surgical technique, virgin hogs were randomized to receive SprayShield™ or good surgical technique (Control). Compared to Controls, SprayShield™ demonstrated a statistically significant reduction in the number of adhesions (46%, p=0.04) and in the area of adhesions (83%, p=0.012) to injured sites. With its ease of application, biocompatibility and adhesion prevention efficacy, SprayShield™ may be an effective next-generation adhesion prevention product for open and laparoscopic abdominopelvic procedures as an adjunct to good surgical technique.

Reduction of postoperative adhesions after laparoscopic gynecological surgery with Oxiplex/AP Gel: a pilot study.

OBJECTIVE: To determine whether Oxiplex/AP Gel (FzioMed, San Luis Obispo, CA) was safe and preliminarily effective in reducing postsurgical adhesions after adnexal surgery by laparoscopy. DESIGN: Prospective, multicenter, double-blind, randomized, U.S. Food and Drug Administration-monitored feasibility study. SETTING: University and private clinics. PATIENT(S): Patients undergoing laparoscopic surgery with pelvic adhesions, tubal occlusion, endometriosis, and/or dermoids were randomized to receive Oxiplex/AP Gel or no further treatment after surgery. INTERVENTION(S): A blinded, parallel-group design was conducted at six centers. Patients (aged 18-46 years) underwent laparoscopic surgery, with second-look surgery 6-10 weeks later. Surgeries were videotaped. Oxiplex/AP Gel was used to cover adnexa and adjacent tissue. MAIN OUTCOME MEASURE(S): Blinded reviews of videotapes were quantitated with the American Fertility Society adhesion score (AFS score). RESULT(S): In 18 treatment patients, surgery was performed on 29 adnexa. Application of Oxiplex/AP Gel required approximately 90 seconds. In 10 control patients, surgery was performed on 18 adnexa. The mean baseline AFS score for each group was 8.0. At second look, treated adnexa had the same score (8.1), whereas in control adnexa the score increased (from 8.0 to 11.6). Thirty-four percent of treated adnexa increased in adhesion score, in contrast to 67% of control adnexa. There were no device-related adverse events. CONCLUSION(S): In this pilot study, Oxiplex/AP Gel was safe, easy to use with laparoscopy, and produced a reduction in the increase of adnexal adhesion scores.