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Local Warming of Surgical Incisions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01026259
First Posted: December 4, 2009
Last Update Posted: December 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Washington
  Purpose
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.

Condition Intervention Phase
Surgical Wound Infection Other: Warming of surgical incision Other: Warming dressing without actual warming Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Local Warming: Effects on Wound Infection and Healing

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: Within 6 weeks of the surgical procedure ]

Secondary Outcome Measures:
  • Wound tissue response [ Time Frame: First 9 days after surgery ]

Enrollment: 146
Study Start Date: October 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026259


Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
  More Information

Responsible Party: JoAnne Whitney, University of Washington
ClinicalTrials.gov Identifier: NCT01026259     History of Changes
Other Study ID Numbers: 29991-A
First Submitted: December 2, 2009
First Posted: December 4, 2009
Last Update Posted: December 4, 2009
Last Verified: December 2009

Keywords provided by University of Washington:
Surgical site infection
wound healing
tissue oxygen
angiogenesis
flow cytometry
immunohistochemistry

Additional relevant MeSH terms:
Infection
Wound Infection
Surgical Wound
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes