Local Warming of Surgical Incisions

December 3, 2009 updated by: University of Washington

Local Warming: Effects on Wound Infection and Healing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Local incision warming
Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.
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.
ACTIVE_COMPARATOR: No warming to surgical incision
Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.
Other: Warming dressing without actual warming
The same type of surgical incision dressing is used but no warming treatments are administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection
Time Frame: Within 6 weeks of the surgical procedure
Within 6 weeks of the surgical procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Wound tissue response
Time Frame: First 9 days after surgery
First 9 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (ESTIMATE)

December 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2009

Last Update Submitted That Met QC Criteria

December 3, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29991-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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