NCT01026259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

4.1 years

First QC Date

December 2, 2009

Last Update Submit

December 3, 2009

Conditions

Surgical Wound Infection

Keywords

Surgical site infectionwound healingtissue oxygenangiogenesisflow cytometryimmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    Within 6 weeks of the surgical procedure

Secondary Outcomes (1)

  • Wound tissue response

    First 9 days after surgery

Study Arms (2)

Local incision warming

EXPERIMENTAL

Local warming applied to surgical incision for 6 treatments beginning in post anesthesia recovery through the second postoperative day.

Other: Warming of surgical incision

No warming to surgical incision

ACTIVE COMPARATOR

Incisions covered with same postoperative dressing as in Arm 1 but without warming treatments.

Other: Warming dressing without actual warming

Interventions

Warming of surgical incisionOTHER

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.

Local incision warming
Warming dressing without actual warmingOTHER

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

No warming to surgical incision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and older,
  • scheduled for bariatric, colon or gynecological surgery,
  • able to speak and read English.

You may not qualify if:

  • glucocorticoids greater than 5 mg per day,
  • albumin below 3.0,
  • creatinine above 2.5 mg/dl,
  • history of pulmonary edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 4, 2009

Study Start

October 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

US(1)