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Poly (Glycerol Sebacate) Film Prevents Formation of Viscero-Parietal Peritoneal Adhesions

Howard Pryor II, MD, Elisabeth O’ Doherty, David Hoganson, MD, Alison Hart, Peter Masiakos, MD, Cathryn Sundback, ScD
Massachusetts General Hospital; Boston, MA


PURPOSE OF STUDY
Abdominal procedures result in adhesion formation in nearly 95% of cases and viscero-partietal (VP) peritoneal adhesions lead to serious post-operative complications. One method to prevent adhesion formation is the interposition of a barrier between damaged areas until adhesion-free healing has occurred. Current barrier products are fraught with drawbacks including poor degradability, variable efficacy and difficulty of use. Poly (glycerol sebacate) (PGS) is a non-immunogenic, biodegradable, and easy-to-use polymer that was evaluated in the rat model as a VP-adhesion prevention barrier.

METHODS USED:
Forty-one rats underwent a midline laparotomy. A 1 cm X 2 cm parietal peritoneal defect was created and the cecum was abraded until petechial bleeding was observed. One PGS film was implanted between the visceral organs and the posterior abdominal wall of 21 animals forming the study group. Twenty control animals did not receive a PGS implantation. Animals were sacrificed at 3, 5, and 8 weeks and their abdomens were inspected for the presence of VP-adhesions.

SUMMARY OF RESULTS:
Overall, VP-adhesions were seen in 15 of 20 (75%) animals in the control group and 1 of 21 (4.8%) for the study group (p<0.001).

CONCLUSIONS:
PGS films reduced adhesion formation by 94% in the study cohort versus the control cohort over 8 weeks. This demonstration of efficacy indicates that PGS films warrant further evaluation as a preventative barrier to the formation of VP-adhesions. Development of such a barrier would be beneficial for patients who are prone to adhesions and re-operation, such as those with Crohn’s disease or acute diverticulitis.

TABLES AND CHARTS:
Adhesion Percentage Rate and Average Severity (* p<0.001)
  3 weeks (ns=3/nc=3) 5 weeks (ns=9/nc=8)* 8 weeks (ns=9/nc=9)* Total (ns=21/nc=20)*
  Percent Avg. Severity Percent Avg. Severity Percent Avg. Severity Percent Avg. Severity
Study 0% 0 + 0 11% 0.3 + 1.0 0% 0 + 0 5% 0.1 + 0.7
Control 66% 2.0 + 1.7 88% 2.6 + 1.1 66% 1.6 + 1.4 75% 2.1 + 1.4

 

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