Clinical trial · Interventional
Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
NCT00981110CI-TRIAL-00008007AMcompletedPhase 3ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AQUAGEL Ag Hydrofiber Wound Dressing | Device | — | UNRESOLVED |
| Mepore Self-adhesive absorbent dressing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mepore Self-adhesive absorbent dressing
- description
- Mepore Self-adhesive absorbent dressing
- interventionNames
- Device: Mepore Self-adhesive absorbent dressing
- type
- EXPERIMENTAL
- label
- AQUAGEL Ag Hydrofiber Wound Dressing
- description
- AQUAGEL Ag Hydrofiber Wound Dressing
- interventionNames
- Device: AQUAGEL Ag Hydrofiber Wound Dressing
Primary outcomes (1)
- measure
- The rate of patients with a Surgical site infection
- timeFrame
- 30 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven) * Age 18-75 * Informed signed consent * Performance Status 0-2 (according to ECOG score) * Platelets \> 50.000/mm3 * Prothrombin Time (Quick) \> 60% * White Blood Cells \> 2500/mm3 * Life Expectancy \> 3 months Exclusion Criteria: * Intestinal obstruction * Severe intestinal bleeding requiring blood transfusion * Age under 18 or over 75 * Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy) * Renal failure (hemodialysis, creatinin \> 2.5 mg/dL) * Active infections * Coagulopathy * Inability to give an informed consent * Known allergies to dressing components
References
Publications (1)
- DERIVEDBiffi R, Fattori L, Bertani E, Radice D, Rotmensz N, Misitano P, Cenciarelli S, Chiappa A, Tadini L, Mancini M, Pesenti G, Andreoni B, Nespoli A. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver. World J Surg Oncol. 2012 May 23;10:94. doi: 10.1186/1477-7819-10-94. PMID 22621779