Local Warming of Surgical Incisions

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