Clinical trial · Interventional
Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery
Efficacy of a Disposable Negative Wound Pressure Device in Reducing the Incidence of Non-organ Space Surgical Site Infection After Clean-contaminated Pancreatic Resections: a Randomized Controlled Trial
NCT03700086CI-TRIAL-00045007completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A disposable negative wound pressure device will be compared to standard sterile wound dressing in reducing the rate of wound infection after clean-contaminated surgical procedures on biliary tract and pancreas in patients at high risk for wound infection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Surgical Site Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disposable negative wound pressure device (PICO) | Device | — | UNRESOLVED |
| OPsite post-op visible standard sterile dressing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative wound pressure device (PICO)
- description
- The disposable negative wound pressure device (PICO) will be used to cover the midline incision. The dressing is changed on POD3 and removed on POD7. Data are collected on POD3, POD7 and POD30.
- interventionNames
- Device: Disposable negative wound pressure device (PICO)
- type
- ACTIVE_COMPARATOR
- label
- Standard sterile dressing
- description
- The OPsite post-op visible standard sterile dressing will be used to cover the midline incision. Dressing is changed q48h. Data are collected on POD3, POD7 and POD30.
- interventionNames
- Device: OPsite post-op visible standard sterile dressing
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 * Informed consent * HPB clean-contaminated procedures (PD, TP and GEA/HJ) * Median laparotomy * Compliance with a follow-up protocol * High risk for SSI (at least one of the following): * Body Mass Index \> 30kg/m2 * Diabetes mellitus type I or II * Use of steroids * Neoadjuvant therapy * ASA ≥ 3 * Charlson Comorbidity Index 1 * Time of surgery \> 360' * Estimated blood loss \> 1L Exclusion Criteria: * Previous open surgery of the abdomen * Unable to give informed consent
References
Publications (21)
- RESULTFiorio M, Marvaso A, Vigano F, Marchetti F. Incidence of surgical site infections in general surgery in Italy. Infection. 2006 Dec;34(6):310-4. doi: 10.1007/s15010-006-6632-0. PMID 17180584
- RESULTAllegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, Pittet D. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15;377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. Epub 2010 Dec 9. PMID 21146207
- RESULTMangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available. PMID 10219875
- RESULTCeppa EP, Pitt HA, House MG, Kilbane EM, Nakeeb A, Schmidt CM, Zyromski NJ, Lillemoe KD. Reducing surgical site infections in hepatopancreatobiliary surgery. HPB (Oxford). 2013 May;15(5):384-91. doi: 10.1111/j.1477-2574.2012.00604.x. Epub 2012 Nov 5. PMID 23557410
- RESULTArgenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577. PMID 9188971
- RESULTMorykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001. PMID 9188970
- RESULTMasden D, Goldstein J, Endara M, Xu K, Steinberg J, Attinger C. Negative pressure wound therapy for at-risk surgical closures in patients with multiple comorbidities: a prospective randomized controlled study. Ann Surg. 2012 Jun;255(6):1043-7. doi: 10.1097/SLA.0b013e3182501bae.