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

Surgical Site Infection Clinical Trial

Official title:

Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Clean-contaminated and Contaminated Surgical Wound of Abdominal Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05865821
• Other study ID #: MURA2023/168
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: March 30, 2025
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection

Intervention

Procedure:
• Negative pressure drainage
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

Other:
• No pressure drain
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

Locations

Country	Name	City	State
Thailand	Chairat Supsamutchai	Bangkok	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	post operation day 3
Primary	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	post operation day 5
Primary	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	post operation day 7
Primary	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	post operation day 14
Secondary	Length of hospital stay	amount of days that the patient stay in hospital since admission date until discharged from the hospital.	day 3
Secondary	Length of hospital stay	amount of days that the patient stay in hospital since admission date until discharged from the hospital.	day 5
Secondary	Length of hospital stay	amount of days that the patient stay in hospital since admission date until discharged from the hospital.	day 7
Secondary	Length of hospital stay	amount of days that the patient stay in hospital since admission date until discharged from the hospital.	day 14
Secondary	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	day 7
Secondary	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	day 14