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

Primary Purpose

Surgical Site Infections, Gastric Cancer, Dehiscence of Laparotomy Wound

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Group A (povidone-iodine wash the surgical incision)

Group B (normal saline wash the surgical incision)

About this trial

This is an interventional treatment trial for Surgical Site Infections focused on measuring gastric cancer, gastrectomy, laparotomy, SSIs, povidone-iodine, normal saline

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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.

Sites / Locations

West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A (povidone-iodine group)

Group B (normal saline group)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02436395

First Posted

December 7, 2014

Last Updated

December 7, 2017

Sponsor

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02436395

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West China Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Standard Operating Procedure (SOP) Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infections, Gastric Cancer, Dehiscence of Laparotomy Wound

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A (povidone-iodine group)

Arm Type

Experimental

Arm Description

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.

Arm Title

Group B (normal saline group)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Group A (povidone-iodine wash the surgical incision)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Group B (normal saline wash the surgical incision)

Intervention Description

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

Primary Outcome Measure Information:

Title

Superficial incisional surgical site infections

Description

Time Frame

30-day of postoperative duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-Han Zhang, M.D.

weihanwch@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

West China Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

West China Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei-Han Zhang, M.D.

weihanwch@126.com

First Name & Middle Initial & Last Name & Degree

Xin-Zu Chen, M.D.

chen_xz_wch_scu@126.com

First Name & Middle Initial & Last Name & Degree

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

First Name & Middle Initial & Last Name & Degree

Wei-Han Zhang, M.D.

First Name & Middle Initial & Last Name & Degree

Xin-Zu Chen, M.D.

12. IPD Sharing Statement

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

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