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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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure drainage | Active Comparator | 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 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. |
|
| No pressure drain | Other | no drainage catheter in subcutaneous surgical wound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure drainage | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | amount of days that the patient stay in hospital since admission date until discharged from the hospital. | day 3 |
| Length of hospital stay | amount of days that the patient stay in hospital since admission date until discharged from the hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chairat Supsamutchai, MD | Ramahibodi hospital, Mahidol University | Study Chair |
| Ninnat Fongsupa, MD | Ramahibodi hospital, Mahidol University | Principal Investigator |
| Napaphat Poprom, Ph.D | Ramahibodi hospital, Mahidol University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chairat Supsamutchai | Bangkok | Bankok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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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 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.
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Investigator
|
| No pressure drain | Other | 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 |
|
| day 5 |
| Length of hospital stay | amount of days that the patient stay in hospital since admission date until discharged from the hospital. | day 7 |
| Length of hospital stay | amount of days that the patient stay in hospital since admission date until discharged from the hospital. | day 14 |
| 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 |
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |