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Completed

NCT Number: NCT01026259

Local Warming of Surgical Incisions

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.

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warming of surgical incision

Other

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.

Warming dressing without actual warming

Other

The same type of surgical incision dressing is used but no warming treatments are administered.

Primary outcomes

  1. Surgical site infection

    Time frame: Within 6 weeks of the surgical procedure

Secondary outcomes

  1. Wound tissue response

    Time frame: First 9 days after surgery

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Local Warming: Effects on Wound Infection and Healing

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2009
Registry last updated
Dec 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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