Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery

NCT06063629 | Not Yet Recruiting

• 1 other identifier: 030/2565
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4). The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (5)

• Rate of Surgical Site Infection (SSI)

  The rate of SSI will be compared between the drain and no drain group

  Post operation day 3

• Rate of Surgical Site Infection (SSI)

  The rate of SSI will be compared between the drain and no drain group

  Post operation day 5

• Rate of Surgical Site Infection (SSI)

  The rate of SSI will be compared between the drain and no drain group

  Post operation day 7

• Rate of Surgical Site Infection (SSI)

  The rate of SSI will be compared between the drain and no drain group

  Post operation day 14

• Rate of Surgical Site Infection (SSI)

  The rate of SSI will be compared between the drain and no drain group

  Post operation day 30

Secondary Outcomes (5)

• Length of hospital stay

  Post operation day 3

• Length of hospital stay

  Post operation day 5

• Length of hospital stay

  Post operation day 7

• Length of hospital stay

  Post operation day 14

• Length of hospital stay

  Post operation day 30

Study Arms (2)

Subcutaneous drain

EXPERIMENTAL

The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.

Procedure: Subcutaneous drain

No drain

OTHER

No drain will be inserted into the surgical wound in this arm.

Procedure: No drain

Interventions

Subcutaneous drain PROCEDURE

The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.

Subcutaneous drain

No drain PROCEDURE

No drain will be inserted into patients allocated to this group

No drain

Eligibility Criteria

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

You may qualify if:

• Age equal or over 18 years old
• Admitted to Queen Savang Vadhana Memorial Hospital
• Receive abdominal surgery and were classified as class 3 or 4 wound

You may not qualify if:

• Patients who undergo operation for ostomy
• Patients who do not receive appropriate antibiotics
• Patients who undergo operation before full recover of prior operation
• Patients who undergo laparoscopic operation
• Pregnant women
• Patients who had history of prior radiation therapy at abdomen
• Patient with immunocompromised status
• Patient with chronic skin disease

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Minimization randomization

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 2, 2023
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04