N/A
Completed N=164
Negative Pressure Wound Therapy to Reduce Surgical Site Infection
Patients Undergoing Hepatopancreatobiliary Surgery
Source: ClinicalTrials.gov NCT01905397 ↗
Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Participants With a Surgical Site Infection — 14; 20 Participants — p=0.27
Summary
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Surgical Site Infection |
14; 20 | 0.27 |
| SECONDARY Number of Surgical Site Infections by Type |
7; 7; 2; 6; 7; 10 | — |
| SECONDARY Length of Hospital Stay |
8; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Female and male patients 18 years of age or older
- Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
Exclusion Criteria
- The need for emergency surgery.
- The need for use of only laparoscopic surgery.
- Presence of bowel obstruction, strangulation, peritonitis or perforation.
- The presence of local or systemic infection preoperatively.
- ASA class ≥4.
- Inability to provide informed consent and authorization.
- Known allergy or hypersensitivity to silver.
- Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.
Data sourced from ClinicalTrials.gov (NCT01905397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.