NCT03057249

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

February 1, 2017

Enrollment Period

5.9 years

First QC Date

February 15, 2017

Last Update Submit

April 16, 2019

Conditions

Keywords

SurgeryThermographyPerfusionImaging

Outcome Measures

Primary Outcomes (1)

  • Perfusion dynamics following surgical procedures

    DIRT findings on the abdominal wall after three different types of surgery

    First five postoperative days

Interventions

Evaluating abdominal skin perfusion with DIRT

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for 1. Abdominoplasty 2. DIEP breast reconstruction 3. Aorta stenting

You may qualify if:

  • Patients scheduled for
  • Abdominoplasty
  • DIEP breast reconstruction
  • Aorta stenting

You may not qualify if:

  • Surgery not indicated Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (10)

  • Nahai F, Brown RG, Vasconez LO. Blood supply to the abdominal wall as related to planning abdominal incisions. Am Surg. 1976 Sep;42(9):691-5. No abstract available.

  • Boltz MM, Hollenbeak CS, Julian KG, Ortenzi G, Dillon PW. Hospital costs associated with surgical site infections in general and vascular surgery patients. Surgery. 2011 Nov;150(5):934-42. doi: 10.1016/j.surg.2011.04.006. Epub 2011 Jun 15.

  • Broex EC, van Asselt AD, Bruggeman CA, van Tiel FH. Surgical site infections: how high are the costs? J Hosp Infect. 2009 Jul;72(3):193-201. doi: 10.1016/j.jhin.2009.03.020. Epub 2009 May 31.

  • Hunt TK, Hopf H, Hussain Z. Physiology of wound healing. Adv Skin Wound Care. 2000 May-Jun;13(2 Suppl):6-11.

  • Sen CK. Wound healing essentials: let there be oxygen. Wound Repair Regen. 2009 Jan-Feb;17(1):1-18. doi: 10.1111/j.1524-475X.2008.00436.x.

  • Huger WE Jr. The anatomic rationale for abdominal lipectomy. Am Surg. 1979 Sep;45(9):612-7.

  • Mayr M, Holm C, Hofter E, Becker A, Pfeiffer U, Muhlbauer W. Effects of aesthetic abdominoplasty on abdominal wall perfusion: a quantitative evaluation. Plast Reconstr Surg. 2004 Nov;114(6):1586-94. doi: 10.1097/01.prs.0000138757.33998.ee.

  • Dhar SC, Taylor GI. The delay phenomenon: the story unfolds. Plast Reconstr Surg. 1999 Dec;104(7):2079-91. doi: 10.1097/00006534-199912000-00021.

  • de Weerd L, Miland AO, Mercer JB. Perfusion dynamics of free DIEP and SIEA flaps during the first postoperative week monitored with dynamic infrared thermography. Ann Plast Surg. 2009 Jan;62(1):42-7. doi: 10.1097/SAP.0b013e3181776374.

  • de Weerd L, Mercer JB, Weum S. Dynamic infrared thermography. Clin Plast Surg. 2011 Apr;38(2):277-92. doi: 10.1016/j.cps.2011.03.013.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Louis de Weerd, MD PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 20, 2017

Study Start

January 1, 2013

Primary Completion

November 16, 2018

Study Completion

January 1, 2019

Last Updated

April 18, 2019

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

The study is based on qualitative evaluation of individual thermographic images that are not suitable for public sharing

Locations