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

Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Abdominal Surgery Wound Class III and IV

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Procedure: Subcutaneous drain; Procedure: No drain

Detailed Description

This study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain.

The participants in this study will know the details about the presence of their drain placement after the operation. If the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. The primary outcome of this study is the occurrence of SSI, which will be tracked up to 30 days post-operation. The patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of SSI. In situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits.

If SSI is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. Complications of SSI will also be noted. Patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of SSI between each group.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcutaneous drain; The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.	Procedure: Subcutaneous drain; The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.
Other: No drain; No drain will be inserted into the surgical wound in this arm.	Procedure: No drain; No drain will be inserted into patients allocated to this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 3
Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 5
Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 7
Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 14
Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 30

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: 030/2565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No