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Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Surgical Wound of Abdominal Surgery

Primary Purpose

Surgical Site Infection

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Negative pressure drainage
No pressure drain
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring abdominal surgery, surgical site infection

Eligibility Criteria

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

Inclusion Criteria: Patients undergoing intra-abdominal surgery on the upper and lower gastrointestinal tract, pancreas and biliary tract. Aged 18 years or older Be in good health and full of consciousness. Willing to participate in the research study project by signing Exclusion Criteria: Patients with thrombocytopenia thrombocytopenia or coagulation disorder The study participant refuses or withdraws from the study.

Sites / Locations

  • Chairat Supsamutchai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Negative pressure drainage

No pressure drain

Arm Description

Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.

no drainage catheter in subcutaneous surgical wound

Outcomes

Primary Outcome Measures

Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage

Secondary Outcome Measures

Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Score of Quality of life
Quality of life is patient's physical health and mental health. We collect this data by 36-Item Short Form Survey Instrument (SF-36) survey at the 7th day and 14th day after being discharged from the hospital
Score of Quality of life
Quality of life is patient's physical health and mental health. We collect this data by 36-Item Short Form Survey Instrument (SF-36) survey at the 7th day and 14th day after being discharged from the hospital

Full Information

First Posted
May 4, 2023
Last Updated
May 18, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05865821
Brief Title
Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Surgical Wound of Abdominal Surgery
Official Title
Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Clean-contaminated and Contaminated Surgical Wound of Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
March 6, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Surgical site infection (SSI) is one of main complication in surgery. It usually occurs within 30 days post operation. The superficial SSI is an infection of skin and subcutaneous layer, clinically presented by pus oozing. Furthermore, seroma hematoma and wound dehiscence are also clinical signs of superficial SSI. Nowadays, there are studies which report methods reducing SSI by placing negative pressure drain within surgical wound. It can reduce serum in subcutaneous layer which is found in every surgical wound, especially in clean-contaminated and contaminated wound. Many studies show that placing negative pressure drainage within a surgical wound can reduce superficial SSI and decrease hospital length of stay by comparing with the control group. The objective in this study to compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage.
Detailed Description
This study is a randomized controlled trial, double-blinded and performs in the patient who underwent intra-abdominal surgery. the investigators collect the data at the department of surgery, Ramathibodi hospital. This study randomized the volunteer patient into 2 groups as follow: the patient with placing negative pressure drainage within the surgical wound and the patient without placing negative pressure drainage. Randomization To minimize the study bias, the investigators random patient into two groups by the unassociated personnel opens an enclosed envelope after the surgical procedure is completely performed and before the beginning of closing the skin layer. Blind process This study does not conceal information about surgical technique and drain placing method. However, the investigators have controlled various surgical procedures to reduce inequality in assessment and bias. Negative pressure drainage is a drainage catheter which is placed in surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure. Surgical site infection (SSI) is infection at surgical wound which happens within 30 days post operatively and in this study will use in term of superficial SSI (pus oozing, cellulitis and wound culture positive) If patients have SSI, the investigators remove the drain from the patients (intervention group) and may total stitch off suture then wet dressing combine with antibiotic. the investigators evaluate and collect data by physical examination at post operation day 3, day 5,day 7 and the day that patient is discharged from hospital. Then investigators follow up the patients at 14 days and 30 days after discharged from hospital.The complication of SSI is seroma, hematoma and wound dehiscence. Seroma is the retention of clear fluid in the cavity of the body such as a surgical wound. Typical clinical presentation is fluid oozing from the wound. Hematoma is the retention of bloody fluid in the cavity of the body such as a surgical wound. It can be infected which is possible to prevent by stop bleeding intraoperatively and evaluate surgical wound every day. Wound dehiscence is partial or total separation of previously approximated wound edges, due to failure of proper wound healing. In patient case with infected wound and the investigators give antibiotics along with dressing, but does not stitch off suture, we do not include as SSI in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
abdominal surgery, surgical site infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.
Masking
Investigator
Masking Description
Investigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative pressure drainage
Arm Type
Active Comparator
Arm Description
Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.
Arm Title
No pressure drain
Arm Type
Other
Arm Description
no drainage catheter in subcutaneous surgical wound
Intervention Type
Procedure
Intervention Name(s)
Negative pressure drainage
Intervention Description
Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter or Redivac is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure
Intervention Type
Other
Intervention Name(s)
No pressure drain
Intervention Description
Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter or Redivac is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure
Primary Outcome Measure Information:
Title
Rate of SSI
Description
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Time Frame
post operation day 3
Title
Rate of SSI
Description
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Time Frame
post operation day 5
Title
Rate of SSI
Description
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Time Frame
post operation day 7
Title
Rate of SSI
Description
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Time Frame
post operation day 14
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Time Frame
day 3
Title
Length of hospital stay
Description
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Time Frame
day 5
Title
Length of hospital stay
Description
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Time Frame
day 7
Title
Length of hospital stay
Description
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Time Frame
day 14
Title
Score of Quality of life
Description
Quality of life is patient's physical health and mental health. We collect this data by 36-Item Short Form Survey Instrument (SF-36) survey at the 7th day and 14th day after being discharged from the hospital
Time Frame
day 7
Title
Score of Quality of life
Description
Quality of life is patient's physical health and mental health. We collect this data by 36-Item Short Form Survey Instrument (SF-36) survey at the 7th day and 14th day after being discharged from the hospital
Time Frame
day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing intra-abdominal surgery on the upper and lower gastrointestinal tract, pancreas and biliary tract. Aged 18 years or older Be in good health and full of consciousness. Willing to participate in the research study project by signing Exclusion Criteria: Patients with thrombocytopenia thrombocytopenia or coagulation disorder The study participant refuses or withdraws from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chairat Supsamutchai, MD
Organizational Affiliation
Ramahibodi hospital, Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ninnat Fongsupa, MD
Organizational Affiliation
Ramahibodi hospital, Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Napaphat Poprom, Ph.D
Organizational Affiliation
Ramahibodi hospital, Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Chairat Supsamutchai
City
Bangkok
State/Province
Bankok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Surgical Wound of Abdominal Surgery

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