Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs (NCT02436395) | Clinical Trial Compass
UnknownNot Applicable
Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs
China340 participantsStarted 2015-05
Plain-language summary
Surgical site infections (SSIs) is one of the most common complications of upper abdominal surgery. Previous studies found that type of surgical incision, emergency operation or not, surgical duration, age of patient, body mass index, malignance duration, malnutrition, complications (diabetes, shock, anemia et al) and drug (Long-term use of corticosteroids) are closely associated with the incidence of SSIs. The general incidence rate of SSIs was about 5% to 40%, although using the preoperative skin disinfectant and other methods to prevent and reduce the SSIs. And for the gastrointestinal surgery, due to the potential risk of infection, SSIs is an important problem which cannot be ignored. On the other hand, gastric cancer is one of the most common digestive system tumors, and gastrectomy is the primary therapeutic options. Therefore, it is important to compare the whether the different liquid (1% povidone-iodine solution or the 0.9% normal saline) wash the incision can influent the incidence of the SSIs.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy;
✓. Without serious disease and malignance disease;
✓. WHO performance score ≤2, ASA score ≤3;
✓. No limit to sexual and race;
✓. Informed consent required.
Exclusion criteria
✕. Emergence operation, because of obstruction, perforate, acute hemorrhage and et al;
✕. Patients with laparoscopic or laparoscopic-assisted gastrectomy
✕. Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
✕. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
✕. Severity mental diseases;
✕. Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery;
✕. After signature the Clinical trial agreement, patients and their agent will quit the trial.