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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01026259
Other study ID # 29991-A
Secondary ID
Status Completed
Phase Phase 3
First received December 2, 2009
Last updated December 3, 2009
Start date October 2005
Est. completion date November 2009

Study information

Verified date December 2009
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 and older,

- scheduled for bariatric, colon or gynecological surgery,

- able to speak and read English.

Exclusion Criteria:

- glucocorticoids greater than 5 mg per day,

- albumin below 3.0,

- creatinine above 2.5 mg/dl,

- history of pulmonary edema.

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


Intervention

Other:
Warming of surgical incision
A warming pack (chemical activation) is applied to the dressing over the surgical incision, warming to 38 degrees C, for a period of 90 minutes times 6 treatments. The first treatment occurs in the PACU.
Warming dressing without actual warming
The same type of surgical incision dressing is used but no warming treatments are administered.

Locations

Country Name City State
United States University of Washington Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical site infection Within 6 weeks of the surgical procedure No
Secondary Wound tissue response First 9 days after surgery No
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