Hepatobiliary Disease, Hepatobiliary Disorders, Surgical Site Infection
Conditions
Keywords
Hepatopancreatobiliary surgery, Surgical site infection, Negative pressure wound therapy
Brief summary
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.
Interventions
OTHERNegative Pressure Wound Therapy
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.
Sponsors
Murk Niaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of incisional surgical site infections (iSSIs) | within 7 days of hepatopancreatobiliary (HPB) surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic therapy | Day 1 to day 30 | Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis. |
| Length of hospital stay. | Day 1 to day 30 | Length of hospital stay. |
| Wound infections | day 7 till 30 days following HPB surgery | Wound infections after day 7 till 30 days following HPB surgery. |
| Surgical site complication | within 30 days of HPB surgery | Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery. |
| Rate of fascial dehiscence | within 30 days of HPB surgery | Rate of fascial dehiscence within 30 days of HPB surgery. |
Countries
Pakistan
Outcome results
None listed