Local Warming of Surgical Incisions

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University of Washington

Status and phase

Completed
Phase 3

Conditions

Surgical Wound Infection

Treatments

Other: Warming of surgical incision
Other: Warming dressing without actual warming

Study type

Interventional

Funder types

Other

Identifiers

NCT01026259
29991-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

146 participants in 2 patient groups

Local incision warming
Experimental group
Description:
Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.
Treatment:
Other: Warming of surgical incision
No warming to surgical incision
Active Comparator group
Description:
Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.
Treatment:
Other: Warming dressing without actual warming

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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