Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous drain | Experimental | The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study. |
|
| No drain | Other | No drain will be inserted into the surgical wound in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous drain | Procedure | The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Minimization randomization
Not provided
Not provided
Not provided
Not provided
| No drain | Procedure | No drain will be inserted into patients allocated to this 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |