Wounds and Injuries

All Conditions

Neoplasms

Digestive System Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Communicable Diseases

Surgical Wound

Surgical Wound Infection

Wound Infection

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Postoperative Complications

Stomach Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Blood Substitutes

Micronutrients

Povidone-Iodine

Povidone

Iodine

Cadexomer iodine

Plasma Substitutes

Anti-Infective Agents, Local

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.

The surgical incision is washed by the 500ml 0.9% normal saline.

We declare that we have no conflicts of interest.

Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with povidone-iodine wash the surgical incision

Group A (povidone-iodine wash the surgical incision)

Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with normal saline wash the surgical incision

Group B (normal saline wash the surgical incision)

Wei-Han Zhang, M.D.

Xin-Zu Chen, M.D.

Jian-Kun Hu, M.D.Ph.D.

Jian-Kun Hu, M.D. Ph.D.

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.

Standard Operating Procedure (SOP)

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.

Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs

Comparison the Influence of the Povidone-iodine or the Normal Saline Cleaning the Incision for the Incidence of the Surgical Site Infections for Gastric Cancer Patients With Gastrectomy- Randomized Controlled Trial

The ceriteria for defining a surgical site infection adopt the defination of the Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee.Am J Infect Control. 1999;27(2):97-132; quiz 133-4; discussion 96.

West China Hospital

Prof. of Gastrointestinal Surgery Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs	NCT02436395	Surgical Site I... Gastric Cancer Dehiscence of L...	Group A (povido... Group B (normal...	18 Years - 75 Years	West China Hospital
Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs	NCT02436395	Surgical Site I... Gastric Cancer Dehiscence of L...	Group A (povido... Group B (normal...	18 Years - 75 Years	West China Hospital

Spots Global Cancer Trial Database for group b (normal saline wash the surgical incision)