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The authors examined whether the preoperative serum concentrations of cotinine accurately predict the risk of complications in patients undergoing flap reconstruction of head and neck cancer defects.Patients with incident stage III or IV squamous cell carcinoma of the head and neck undergoing resection with pedicled or free flap reconstruction were selected from an existing database of 500 patients with squamous cell carcinoma of the head and neck who participated in a prospective epidemiologic study and were reviewed retrospectively. Preoperative serum cotinine concentrations were determined using a competitive microplate immunoassay. Complications were defined as any adverse postoperative wound outcome at either the donor or recipient site.Eighty-nine patients underwent 101 flap reconstructions. Thirty-seven wound complications occurred in 33 patients. Forty of the 89 patients had a serum cotinine concentration greater than 10 ng/ml; twenty (50 percent) developed postoperative complications, whereas only 13 of 49 patients (27 percent) with a serum cotinine concentration of 10 ng/ml or less developed complications (p = 0.028). The relative risk of wound complications for those with a cotinine concentration greater than 10 ng/ml was approximately double that of patients with a lower cotinine concentration (relative risk, 1.9; 95 percent CI, 1.1 to 3.3). Patients with a cotinine concentration greater than 50 ng/ml had a particularly high risk (relative risk, 2.3; 95 percent CI, 1.1 to 16.7; p = 0.024). The relative risk of wound complications was not significantly associated with self-reported smoking status or history.A serum cotinine concentration greater than 10 ng/ml may predict an increased risk of wound complication in head and neck flap reconstruction and may serve as an objective, easily measured variable with which to identify patients who may benefit from an aggressive smoking cessation program before surgery.