Local Warming of Surgical Incisions

Phase 3

Completed

• Conditions: Surgical Wound Infection
• Interventions: Other: Warming of surgical incision; Other: Warming dressing without actual warming

• Registration Number: NCT01026259
• Lead Sponsor: University of Washington

Brief 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.

Detailed 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 Timeline

• Study Start: 2005-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2009-12
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-03
• Last Update Submitted: 2009-12-03
• Study First Posted: 2009-12-04
• Last Update Posted: 2009-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• 18 and older,
• scheduled for bariatric, colon or gynecological surgery,
• able to speak and read English.

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Exclusion Criteria

• glucocorticoids greater than 5 mg per day,
• albumin below 3.0,
• creatinine above 2.5 mg/dl,
• history of pulmonary edema.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local incision warming	Warming of surgical incision	Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.
No warming to surgical incision	Warming dressing without actual warming	Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	Within 6 weeks of the surgical procedure

Secondary Outcome Measures

Name	Time	Method
Wound tissue response	First 9 days after surgery

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States