Prevention of postsurgical adhesions by INTERCEED(TC7), an absorbable adhesion barrier: a prospective randomized multicenter clinical study. INTERCEED(TC7) Adhesion Barrier Study Group
Adhesion Barrier Study Group
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Abstract
INTERCEED(TC7) (Johnson & Johnson Patient Care Inc., New Brunswick, NJ) is an absorbable fabric specially designed to reduce postsurgical adhesions. The authors report on a prospective, randomized, multicenter, clinical trial that evaluated the efficacy of Interceed in reducing adhesions in humans. Infertility patients (n = 74) with bilateral pelvic sidewall adhesions were studied at treatment laparotomy and "second-look" laparoscopy to determine Interceed's effectiveness. After removal of adhesions at laparotomy, the deperitonealized area of one pelvic sidewall was covered with Interceed. The contralateral untreated sidewall served as the control. Pelvic sidewalls covered with Interceed had a 90% improvement over control sidewalls in preventing adhesion formation. Additionally, Interceed treatment was associated with a 57% reduction of the extent of adhesion formation over that obtained by microsurgical techniques alone. Interceed also provided a significant benefit in reducing the severity of those adhesions that did form, and significantly reduced the number of adhesions between the ovary and pelvic sidewall. In conclusion, Interceed significantly reduced the incidence, extent, and severity of postsurgical pelvic adhesions.
Adhesion Barrier Study Group (1989). Prevention of postsurgical adhesions by INTERCEED(TC7), an absorbable adhesion barrier: a prospective randomized multicenter clinical study. INTERCEED(TC7) Adhesion Barrier Study Group. Fertility and sterility, 51(6), 933-938.
Adhesion Barrier Study Group. Prevention of postsurgical adhesions by INTERCEED(TC7), an absorbable adhesion barrier: a prospective randomized multicenter clinical study. INTERCEED(TC7) Adhesion Barrier Study Group. Fertil Steril. 1989;51(6):933-938.
Adhesion Barrier Study Group. "Prevention of postsurgical adhesions by INTERCEED(TC7), an absorbable adhesion barrier: a prospective randomized multicenter clinical study. INTERCEED(TC7) Adhesion Barrier Study Group." Fertility and sterility, vol. 51, no. 6, 1989, pp. 933-938.
Nordic Adhesion Prevention Study Group, 1995·Fertil Steril
To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallopian tube, and fimbria when used together with microsurgical techniques. Prospective, randomized, multicenter, controlled clinical study. Normal human volunteers in an academic research environment. Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae. Adhesiolysis bilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the surgeon before application, follow-up laparoscopy 4 to 10 weeks postoperatively, with each patient serving as her own control. Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy. When the initial scores registered at the operation for fertility were compared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a significant reduction of postoperative adhesions. Adnexa, which were covered with Interceed, had significantly lower adhesion scores than the control adnexa, representing an improvement of 39% compared with microsurgery alone (control) in reducing adhesion reformation scores. When combined with microsurgical techniques, Interceed reduced adhesion reformation scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was significantly increased by approximately twofold when organs were covered with Interceed. In a prospective, randomized, multicenter, controlled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce significantly the incidence and severity of adhesion reformation to the ovary, fallopian tube, and fimbria after infertility surgery.
To (1) review the events leading to peritoneal adhesion formation; (2) review traditional adhesion prevention adjuvants; (3) overview studies for adhesion prevention barriers including a perspective for their use; and (4) look toward the future of adhesion prevention. A great deal of effort has been dedicated to reduce adhesion formation because of the morbidity associated with adhesions and the associated economic burden, which considering only hospital costs and surgeons' fees, was $1,180 million in the United States. To understand the role of adhesion barriers in gynecological surgery, an appreciation of the cellular cascade and temporal nature of peritoneal repair is necessary. Evidence indicates that areas denuded of peritoneum will heal satisfactorily and that suturing of the peritoneum may increase adhesion formation. Physical barriers, including both mechanical and viscous solutions, are widely used to prevent adhesion formation by limiting tissue apposition during the critical stages of mesothelial repair. Clinical studies do not support the use of intraperitoneal, dextran for adhesion prevention. Theoretical considerations of peritoneal fluid dynamics indicate that crystalloid instillates should not prevent adhesion formation because of their short intraperitoneal residence. This prediction is consistent with clinical observation. The availability of Interceed (Johnson and Johnson Medical, Inc., Arlington, TX) and Gore-Tex Surgical Membrane (W.L. Gore, Flagstaff, Arizona) barriers provides substantial progress in postsurgical adhesion prevention. Although many investigators are incorporating adhesion prevention barriers into their routine clinical situations, physician acceptance is constrained by technical difficulties.
Eight patients with extensive adhesions and 10 undergoing myomectomy had Gore-Tex surgical membranes placed to prevent adhesion formation/reformation. At the time of second-look laparoscopy, the membranes were removed easily, and the extent of adhesion was minimal. Further studies are ongoing to validate these findings and to compare the Gore-Tex surgical membrane with antiadhesion agents.
We compared nifedipine and ritodrine for treatment of preterm labor with respect to neonatal outcome. We conducted an open randomized multicenter study of neonatal outcome in 185 women who received either oral nifedipine (n = 95) or intravenous (IV) ritodrine (n = 90) for treatment of preterm labor. Secondary outcome measures included neonatal mortality and morbidity, especially neonatal intensive care unit (NICU) admission, respiratory distress syndrome (RDS), and intracranial bleeding. There were no significant differences in umbilical artery pH values and Apgar scores between groups. Nifedipine was associated with lower admission rates to the NICU (49% versus 66%; odds ratio 0. 51, confidence interval 0.28, 0.93) compared with ritodrine, and lower incidences of RDS (21% versus 37%; 0.46, 0.24, 0.89), intracranial bleeding (18% versus 31%; 0.48, 0.24, 0.96), and neonatal jaundice (52% versus 67%; 0.53, 0.29, 0.97). Logistic regression analysis showed that even after correction for gestational age at birth, newborn risk of RDS, intracranial bleeding, or neonatal jaundice was significantly lower in the nifedipine group than the ritodrine group. Nifedipine for treatment of preterm labor was associated with a lower incidence of neonatal morbidity than ritodrine. That difference appeared to be partly because of the higher tocolytic efficacy of nifedipine and partly because of an intrinsic beneficial effect of nifedipine, or the lack of harmful effects when compared with ritodrine.