Local Warming of Surgical Incisions

Surgical Wound Infection Clinical Trial

Official title:

Local Warming: Effects on Wound Infection and Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026259
• Other study ID #: 29991-A
• 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

• Infection
• Surgical Wound Infection
• Wound Infection

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