NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds

Exclusion Criteria

• •Concurrent infections of unremovable prosthetic materials (e.g., permanent cardiac pacemaker battery packs, or joint replacement prostheses).
• •Undergoing a significant major planned concomitant surgical procedure other than hysterectomy or receiving antibiotic therapy within the week (7 days) prior to the date of surgery other than perioperative antibiotic therapy.
• •Preoperative evaluation that suggests an intra-abdominal process that might preclude full closure of the skin by secondary intention.
• •Treatment (e.g., chemotherapy, radiation) for cancer in the last 3 months.
• •Concomitant use of systemic steroid hormones, i.e. \> 10 mg/day prednisone or equivalent.
• •Concomitant use of any immunosuppressive or immunomodulatory drugs.
• •History of Crohn's disease or Ulcerative colitis.
• •Known history of drug or alcohol abuse within the past year. A positive screening urine toxicology will also exclude patients from this study.
• •Medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
• •Preoperative prothrombin time (PT), ALT, AST, and creatinine \> 1.5 times upper limit of normal.
• •Lactating females.
• •Postsurgical life expectancy ≤ 60 days, in the investigator or sponsor's opinion.
• •Refusal to accept medically indicated blood products.
• •Participation within 30 days before the start (dosing) of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
• •Presence of prosthetic cardiac valve.
• •Known medical history (carrier or disease) of human immunodeficiency virus (HIV), Hepatitis A, Hepatitis B, or Hepatitis C, or other diseases known to be autoimmune in origin.
• •Known medical history of tuberculosis or liver cirrhosis.
• •Current or prior treatment with growth factors or hyperbaric therapy in the last 30 days preceding study day 1.
• •History of sensitivity to the study medication, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical/research monitor, contraindicates their participation.
• •Uncontrolled intercurrent illness, including, but not limited to, ongoing or serious active infection (not including eligible surgical wounds), symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, metastatic cancer, chronic obstructive pulmonary disease (COPD; (using home oxygen therapy).
• •Insulin-requiring diabetes.
• •BMI \> 40.
• •Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety of the study drug, or prevent compliance with the study