Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02436395
Status:
UNKNOWN
Last Update Posted:
2017-12-11
First Post:
2014-12-07
Brief Title:
Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 09 normal saline wash the incision can influent the incidence of the SSIs
Detailed Description:
Standard Operating Procedure SOP
1 Preoperative evaluation Patients satisfied with inclusionexclusion 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 400ml09 normal saline and 100 ml5 povidone-iodine solution and patients in the Group B with 500ml 09 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
1 Preoperative evaluation Patients satisfied with inclusionexclusion 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 400ml09 normal saline and 100 ml5 povidone-iodine solution and patients in the Group B with 500ml 09 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None