A modern biomaterial for adhesion prevention.
A biomaterial composed of carboxymethylcellulose, poly(ethylene oxide), and calcium can be prepared in a variety of ways to reduce fibrin deposition and adhesion formation. This biomaterial platform can be formulated into a flowable gel with tissue adherence appropriate for use in minimally invasive surgery. The device remains at the site of placement even in gravitationally dependent areas. A peridural formulation was shown in preclinical studies to be safe and effective in reducing adhesions to dura following spinal surgery. A peritoneal formulation used on pelvic organs following peritoneal cavity surgery was also shown to be safe and effective. A clinical feasibility study showed that patients with severe back pain and lower extremity weakness treated with the peridural formulation, applied over their nerve roots following laminectomy or laminotomy, experienced significantly reduced symptoms when compared with surgery-only controls. The peritoneal formulation was shown in two multicenter feasibility studies of women undergoing pelvic surgery to significantly reduce adhesion formation when compared with surgery-only controls. Confirmation of the feasibility studies awaits results from pivotal clinical trials. These formulations were safe, effective, and easy to use. This biomaterial provided a benefit to patients undergoing surgery where postsurgical adhesion formation is a concern.
diZerega
Gere S
GS
Department of Obstetrics and Gynecology, Livingston Reproductive Biology Laboratories, Keck-USC School of Medicine, Los Angeles, California, USA. dizerega@usc.edu
Cortese
Stephanie
S
Rodgers
Kathleen E
KE
Block
Kathleen M
KM
Falcone
Samuel J
SJ
Juarez
Thomas G
TG
Berg
Richard
R
D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000517:prevention & control*; D011817:Rabbits; D013131:Spine / Q000601:surgery; D000267:Tissue Adhesions / Q000517:prevention & control*
D001672:Biocompatible Materials