Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs
NCT ID: NCT02436395
Last Updated: 2017-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
340 participants
INTERVENTIONAL
2015-05-31
2018-12-31
Brief Summary
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Detailed Description
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1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Randomization: Preoperative evaluation found that total or subtotal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
3. Procedures: The surgical treatments is adopted the conventional open total or subtotal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Patients in the Group A using the mixed solution with 400ml,0.9% normal saline and 100 ml，5%, povidone-iodine solution， and patients in the Group B with 500ml 0.9% normal saline solution to wash the abdominal surgical incision.
4. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
5. Follow-up: Follow-up will last to the 30-day of the postoperative period. The postoperative complications is graded by the Clavien-Dindo classification. And the surgical site infections are the focus of this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A (povidone-iodine group)
The surgical incision is washed by the mixed solution with 400ml 9% normal saline and 100ml 5% povidone-iodine solution.
We declare that we have no conflicts of interest.
Group A (povidone-iodine wash the surgical incision)
Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with povidone-iodine wash the surgical incision
Group B (normal saline group)
The surgical incision is washed by the 500ml 0.9% normal saline.
We declare that we have no conflicts of interest.
Group B (normal saline wash the surgical incision)
Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with normal saline wash the surgical incision
Interventions
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Group A (povidone-iodine wash the surgical incision)
Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with povidone-iodine wash the surgical incision
Group B (normal saline wash the surgical incision)
Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with normal saline wash the surgical incision
Eligibility Criteria
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Inclusion Criteria
2. Predictively resectable diseases, of preoperative staging JGCA 14th Edition cT1N0M0-T4aN+M0, Ia-IIIc stage
3. Age：≤75 years, or ≥18 years;
4. Without serious disease and malignance disease;
5. WHO performance score ≤2, ASA score ≤3;
6. No limit to sexual and race;
7. Informed consent required.
Exclusion Criteria
2. Patients with laparoscopic or laparoscopic-assisted gastrectomy
3. 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;
4. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
5. Severity mental diseases;
6. Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery;
7. After signature the Clinical trial agreement, patients and their agent will quit the trial.
18 Years
75 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Jian-Kun Hu
Prof. of Gastrointestinal Surgery Department
Principal Investigators
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Jian-Kun Hu, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Wei-Han Zhang, M.D.
Role: primary
Xin-Zu Chen, M.D.
Role: backup
Other Identifiers
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WCH-GC-03
Identifier Type: -
Identifier Source: org_study_id