To compare the impact of expanded polytetrafluoroethylene (PTFE; Gore-Tex Surgical Membrane; W. L. Gore & Associates, Inc., Flagstaff, AZ) and oxidized regenerated cellulose (Interceed TC7, Johnson & Johnson Medical, Inc., Arlington, TX) on the development of postsurgical adhesions.
Design
A multicenter, nonblinded, randomized clinical trial.
Setting
University medical centers.
Interventions
Each barrier was allocated randomly to the left or right sidewall of every patient.
Patients
Thirty-two women with bilateral pelvic sidewall adhesions undergoing reconstructive surgery and second-look laparoscopy.
Main Outcome Measures
Adhesion score (on a 0- to 11-point scale), the area of adhesion (cm2), and the likelihood of no adhesions.
Results
The use of both barriers was associated with a lower adhesion score and area of adhesion postoperatively. However, those sidewalls covered with PTFE had a significantly lower adhesion score (0.97 +/- 0.30 versus 4.76 +/- 0.61 points, mean +/- SEM) and area of adhesion (0.95 +/- 0.35 versus 3.25 +/- 0.62 cm2). Overall, more sidewalls covered with PTFE had no adhesions (21 versus 7) and, when adhesions were present on the contralateral sidewall, the number of sidewalls covered with PTFE without adhesions was greater than those covered with oxidized regenerated cellulose (16 versus 2).
Conclusion
Expanded polytetrafluoroethylene was associated with fewer postsurgical adhesions to the pelvic sidewall than oxidized regenerated cellulose.
PMID 7720911 7720911 DOI 10.1016/s0015-0282(16)57541-4 10.1016/s0015-0282(16)57541-4 Haney et al. 1995, Haney 1995
Cite this article
Haney, A. F., Hesla, J., Hurst, B. S., Kettel, L. M., Murphy, A. A., Rock, J. A., Rowe, G., & Schlaff, W. D. (1995). Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Fertility and Sterility, 63(5), 1021-1026. https://doi.org/10.1016/s0015-0282(16)57541-4
Haney AF, Hesla J, Hurst BS, Kettel LM, Murphy AA, Rock JA, Rowe G, Schlaff WD. Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Fertil Steril. 1995;63(5):1021-1026. doi:10.1016/s0015-0282(16)57541-4
Haney, A. F., et al. "Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions." Fertility and sterility, vol. 63, no. 5, 1995, pp. 1021-1026.
To assess the safety and efficacy of Seprafilm (HAL-F), Bioresorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after myomectomy. Prospective, randomized, blinded, multicenter study. Adhesion reduction was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's second-look laparoscopy. Nineteen institutions across the United States. PATIENT(S): One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision > or = 1 cm in length. INTERVENTION(S): Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy. MAIN OUTCOME MEASURE(S): The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy. RESULT(S): The incidence, measured as the mean number of sites adherent to the uterine surface, was significantly less in treated patients (4.98 +/- 0.52 [mean +/- SEM] sites) than in no treatment patients (7.88 +/- 0.48 sites) as were the mean uterine adhesion severity scores (1.94 +/- 0.14 versus 2.43 +/- 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 +/- 0.12 versus 1.68 +/- 0.10), and mean area of adhesions (13.2 +/- 1.67 versus 18.7 +/- 1.66 cm2). No adverse events occurred that were judged to be related to the use of Seprafilm. CONCLUSION(S): In this multicenter study, treatment of patients after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complications.
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.
Myomectomy Adhesion Multicenter Study Group, 1995·Fertil Steril·
To evaluate the effects of the expanded polytetrafluoroethylene barrier (PTFE), Gore-Tex Surgical Membrane, in reducing postmyomectomy adhesion formation. Multicenter randomized clinical trial. Twenty-seven women having myomectomy with at least two incisions on the uterine fundus and posterior uterine wall of similar length were enrolled in the study. At laparotomy, the two incision sites were randomly assigned to be covered with PTFE or were left uncovered. A second-look laparoscopy to evaluate adhesion formation and to lyse adhesions was done from 2 to 6 weeks after the myomectomy. Adhesions were scored using a 0- to 11-point scoring system. At laparoscopy, 15 of 27 incisions covered with PTFE (55.6%) and only 2 of 27 uncovered sites (7.4%) were completely free of adhesions. The mean adhesion score at the PTFE sites was significantly lower (1.88 +/- 0.46; SEM) than at the control sites (7.55 +/- 0.57). The PTFE barrier is effective in reducing postmyomectomy adhesion formation.
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.