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To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group A | Experimental | After the skin closed, negative pressure wound therapy will be applied. |
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| Control group B | No Intervention | After the skin is closed, the wound is covered using sterile standard guaze dressing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Other | The wound is dressed using negative pressure wound therapy comprising of a single layer of sterile gauze followed by placement of a 18 Fr nelaton catheter and the wound further covered with 4 more layers of sterile gauze over the nelaton catheter. The wound is then covered with opsite dressing making it airtight. The nelaton catheter is attached to the wall suction port once the patient is shifted to the bed with pressure set at - 25 mm Hg. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of incisional surgical site infections (iSSIs) | To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing. | within 7 days of hepatopancreatobiliary (HPB) surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infections | Wound infections after day 7 till 30 days following HPB surgery. | day 7 till 30 days following HPB surgery |
| Surgical site complication | Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery. |
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Inclusion Criteria:
All patients undergoing elective open HPB surgery (benign or malignant disease) of age > 18 years consenting to the study protocol.
Exclusion Criteria:
The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).
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| Name | Affiliation | Role |
|---|---|---|
| Uzma Soomro | Sindh Institute of Urology and Transplantation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sindh Institute of Urology and Transplantation | Karachi | Sindh | Pakistan |
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Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
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Two individuals were assigned the role of outcome assessors to examine the wound after removal of the dressing and score the wound for infection using the ASEPSIS score.
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| within 30 days of HPB surgery |
| Rate of fascial dehiscence | Rate of fascial dehiscence within 30 days of HPB surgery. | within 30 days of HPB surgery |
| Antibiotic therapy | Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis. | Day 1 to day 30 |
| Length of hospital stay. | Length of hospital stay. | Day 1 to day 30 |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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