Local Warming of Surgical Incisions

Local Warming: Effects on Wound Infection and Healing

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026259

Enrollment

146

Registered

2009-12-04

Start date

2005-10-31

Completion date

2009-11-30

Last updated

2009-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

Surgical site infection, wound healing, tissue oxygen, angiogenesis, flow cytometry, immunohistochemistry

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.

Interventions

OTHERWarming of surgical incision

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.

OTHERWarming dressing without actual warming

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Surgical site infection	Within 6 weeks of the surgical procedure

Secondary

Measure	Time frame
Wound tissue response	First 9 days after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026