Role of Oxidized Regenerated Cellulose (ORC) Applied to "Dirty" Surgical Wounds
Phase 4
Completed
- Conditions
- Infections
- Interventions
- Device: oxidized regenerated cellulose (Fibrillar SURGICEL)Device: iodoform gauze
- Registration Number
- NCT00947089
- Lead Sponsor
- Catholic University of the Sacred Heart
- Brief Summary
The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).
- Detailed Description
Surgical site infections (SSI) have significant clinical and economic repercussions since they still are the most common cause of nosocomial infections in surgical patients. It is important to bear in mind the growing number of SSI due to antibiotic-resistant microorganisms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
- have an ileostomy or a colostomy
- are candidates for an elective surgical procedure of ostomy closure
Exclusion Criteria
- immunodeficiency
- chronic use of corticosteroids or antibiotics
- chemotherapy and/or radiotherapy in the last 30 days before closure of the stoma
- concomitant foci of infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group A-the treatment group oxidized regenerated cellulose (Fibrillar SURGICEL) Group A-patients have their wound, the site of the previous stoma, wad with ORC group B-the control group iodoform gauze control group-patients have their wound wad with iodoform gauze
- Primary Outcome Measures
Name Time Method to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment third post-operative day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Digestive Surgery of the Catholic University of Sacred Heart
🇮🇹Rome, Italy