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Skin Perfusion After Abdominal Surgery (DIRTSURGERY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057249
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:
The purpose of this study is to evaluate the consequences of 3 selected surgical procedures on abdominal wall perfusion in order to help to reduce postoperative complication related to inadequate tissue perfusion. The selected surgical procedures are a) abdominoplasty, b) breast reconstruction with a free flap from the lower abdomen and c) endovascular stenting of an abdominal aorta aneurism. These operations are all standard surgical procedures frequently performed at the University Hospital of North Norway, Tromsø. The abdominal wall perfusion will be evaluated with the use of Dynamic Infrared Thermography (DIRT).

Condition or disease Intervention/treatment
Surgical Wound Infection Other: Dynamic infrared thermography (DIRT)

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Impact of a Selected Surgical Procedure on Skin Blood Perfusion of the Abdominal Wall Evaluated by Dynamic Infrared Thermography (DIRT)
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : January 1, 2019

Intervention Details:
  • Other: Dynamic infrared thermography (DIRT)
    Evaluating abdominal skin perfusion with DIRT


Primary Outcome Measures :
  1. Perfusion dynamics following surgical procedures [ Time Frame: First five postoperative days ]
    DIRT findings on the abdominal wall after three different types of surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for

  1. Abdominoplasty
  2. DIEP breast reconstruction
  3. Aorta stenting
Criteria

Inclusion Criteria:

Patients scheduled for

  1. Abdominoplasty
  2. DIEP breast reconstruction
  3. Aorta stenting

Exclusion Criteria:

Surgery not indicated Smokers


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057249


Locations
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Norway
University Hospital of North Norway
Tromsø, Troms, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Principal Investigator: Louis de Weerd, MD PhD University Hospital of North Norway
Publications of Results:

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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03057249    
Other Study ID Numbers: 2012/176
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study is based on qualitative evaluation of individual thermographic images that are not suitable for public sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital of North Norway:
Surgery
Thermography
Perfusion
Imaging
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Surgical Wound
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes