Local and Systemic Toxicity in Mice Following Subcutaneous Implantation of Latex Penrose Drains

Penrose drains are widely used in surgical procedures as an aid in wound healing. The studies presented here investigated the potential toxicity associated with the implantation of latex Penrose drains in BALB/c and B6C3F1 mice. Animals were implanted subcutaneously in the dorsal surface of the neck with 100, 150, or 200 mg of Perry latex drain or 200 mg of Bard (comparative control) latex drain for up to 36 hours. High-dose (200 mg) exposure to the Perry drain induced severe local and systemic toxicity, resulting in mortality within 24 hours. Time- and dose-responsive effects included decreased response to stimulus, inflammation at the implantation site, epaxial myositis, lesions consistent with hepatic glycogen depletion, apoptotic necrosis of the adrenal "X zone," and massive thymic apoptosis and atrophy. Negligible levels of endotoxin were quantified from Perry drain samples using the Limulus Amebocyte Lysate Assay. Extraction studies revealed the presence of zinc diethyldithiocarbamate (ZDEC) in the Perry drains but not in the control drains. No other differences were noted from gas chromatography mass spectrometry (GCMS) analyses. Quantitation studies measured ZDEC levels at 2.22 +/- 0.04 mug/mg in Perry samples. When ZDEC was eluted from Perry drains prior to implantation, animals exhibited no signs of toxicity. Although FDA regulations limit accelerators to 1.5% of rubber medical products, these studies indicate that the presence of ZDEC in concentrations lower than 0.25% of the drain weight may induce local toxicity and delayed wound healing.