Local Warming of Surgical Incisions

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01026259
First received: December 2, 2009
Last updated: December 3, 2009
Last verified: December 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Local Warming: Effects on Wound Infection and Healing

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: Within 6 weeks of the surgical procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound tissue response [ Time Frame: First 9 days after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026259

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

No publications provided

Responsible Party: JoAnne Whitney, University of Washington
ClinicalTrials.gov Identifier: NCT01026259     History of Changes
Other Study ID Numbers: 29991-A
Study First Received: December 2, 2009
Last Updated: December 3, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014