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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06063629
• Other study ID #: 030/2565
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Subcutaneous drain
The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.
• No drain
No drain will be inserted into patients allocated to this group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Surgical Site Infection (SSI)	The rate of SSI will be compared between the drain and no drain group	Post operation day 3
Primary	Rate of Surgical Site Infection (SSI)	The rate of SSI will be compared between the drain and no drain group	Post operation day 5
Primary	Rate of Surgical Site Infection (SSI)	The rate of SSI will be compared between the drain and no drain group	Post operation day 7
Primary	Rate of Surgical Site Infection (SSI)	The rate of SSI will be compared between the drain and no drain group	Post operation day 14
Primary	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	Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 3
Secondary	Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 5
Secondary	Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 7
Secondary	Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 14
Secondary	Length of hospital stay	The length of hospital stay will be compared between drain and no drain group	Post operation day 30