Local Warming of Surgical Incisions

Study Overview
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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.

Official Title
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Local Warming: Effects on Wound Infection and Healing

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Other: Warming of surgical incision
* Other: Warming dressing without actual warming


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection |  | Within 6 weeks of the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound tissue response |  | First 9 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical site infection, wound healing, tissue oxygen, angiogenesis, flow cytometry, immunohistochemistry