Local Warming of Surgical Incisions
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Warming of surgical incision
Warming dressing without actual warming
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Surgical site infection, wound healing, tissue oxygen, angiogenesis, flow cytometry, immunohistochemistry
Eligibility 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.
Sites / Locations
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Local incision warming
No warming to surgical incision
Arm Description
Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.
Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.
Outcomes
Primary Outcome Measures
Surgical site infection
Secondary Outcome Measures
Wound tissue response
Full Information
NCT ID
NCT01026259
First Posted
December 2, 2009
Last Updated
December 3, 2009
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT01026259
Brief Title
Local Warming of Surgical Incisions
Official Title
Local Warming: Effects on Wound Infection and Healing
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Surgical site infection, wound healing, tissue oxygen, angiogenesis, flow cytometry, immunohistochemistry
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local incision warming
Arm Type
Experimental
Arm Description
Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.
Arm Title
No warming to surgical incision
Arm Type
Active Comparator
Arm Description
Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.
Intervention Type
Other
Intervention Name(s)
Warming of surgical incision
Intervention Description
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
Intervention Name(s)
Warming dressing without actual warming
Intervention Description
The same type of surgical incision dressing is used but no warming treatments are administered.
Primary Outcome Measure Information:
Title
Surgical site infection
Time Frame
Within 6 weeks of the surgical procedure
Secondary Outcome Measure Information:
Title
Wound tissue response
Time Frame
First 9 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
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Local Warming of Surgical Incisions
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