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Local Warming of Surgical Incisions

NCT ID: NCT01026259

Last Updated: 2009-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Surgical Wound Infection

Keywords

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Surgical site infection wound healing tissue oxygen angiogenesis flow cytometry immunohistochemistry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Local incision warming

Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.

Group Type EXPERIMENTAL

Warming of surgical incision

Intervention Type OTHER

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.

No warming to surgical incision

Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.

Group Type ACTIVE_COMPARATOR

Warming dressing without actual warming

Intervention Type OTHER

The same type of surgical incision dressing is used but no warming treatments are administered.

Interventions

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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.

Intervention Type OTHER

Warming dressing without actual warming

The same type of surgical incision dressing is used but no warming treatments are administered.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Locations

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University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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29991-A

Identifier Type: -

Identifier Source: org_study_id