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Clinical Trial Summary

The purpose of this study is to determine if local warming of surgical wounds improves healing and helps prevent infection. The investigators want to see if warming surgical incisions improves oxygen levels and healing in skin close to the incision.


Clinical Trial Description

Surgical site infections (SSI) account for 37% of US hospital infections and increase morbidity and cost. High rates (10-22%) of SSI are associated with colorectal surgery and obesity. Bacterial resistance requires oxygen and higher tissue oxygen limits infection in general surgery patients. Control of core and local temperature may increase infection resistance by modulating perfusion, oxygenation, angiogenesis and immune cell responses. Perioperative hypothermia reduces tissue oxygen while normothermia lowers SSI rates. Warming injured tissues locally may offer additional benefit. Warming incisions immediately after surgery and intermittently for two days after gastric bypass or colectomy surgery reduced infection rates in a pilot sample. Systematic study of clinical outcomes and potential mechanisms in a larger study is lacking and is the focus of the current study. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01026259
Study type Interventional
Source University of Washington
Contact
Status Completed
Phase Phase 3
Start date October 2005
Completion date November 2009

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