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

NCT02436395 | Unknown DMC

• 1 other identifier: WCH-GC-03
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infections; Gastric Cancer; Dehiscence of Laparotomy Wound

Keywords

gastric cancer; gastrectomy; laparotomy; SSIs; povidone-iodine; normal saline

Outcome Measures

Primary Outcomes (1)

• Superficial incisional surgical site infections

  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.

  30-day of postoperative duration

Study Arms (2)

Group A (povidone-iodine group)

EXPERIMENTAL

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.

Procedure: Group A (povidone-iodine wash the surgical incision)

Group B (normal saline group)

EXPERIMENTAL

The surgical incision is washed by the 500ml 0.9% normal saline. We declare that we have no conflicts of interest.

Procedure: Group B (normal saline wash the surgical incision)

Interventions

Group A (povidone-iodine wash the surgical incision) PROCEDURE

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

Group A (povidone-iodine group)

Group B (normal saline wash the surgical incision) PROCEDURE

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

Group B (normal saline group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy;
• Predictively resectable diseases, of preoperative staging JGCA 14th Edition cT1N0M0-T4aN+M0, Ia-IIIc stage
• Age：≤75 years, or ≥18 years;
• Without serious disease and malignance disease;
• WHO performance score ≤2, ASA score ≤3;
• No limit to sexual and race;
• Informed consent required.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jian-Kun Hu, M.D. Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Han Zhang, M.D.

CONTACT

weihanwch@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Gastrointestinal Surgery Department

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: May 6, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

CN (1)