Surgical Wound InfectionDIRTSURGERYNCT03057249
Skin Perfusion After Abdominal Surgery
An observational study of Surgical Wound Infection, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Dynamic infrared thermography (DIRT)
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2013to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for 1. Abdominoplasty 2. DIEP breast reconstruction 3. Aorta stenting
Who may be able to join
- Patients scheduled for
- Abdominoplasty
- DIEP breast reconstruction
- Aorta stenting
Who cannot join
- Surgery not indicated Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Selected Surgical Procedure on Skin Blood Perfusion of the Abdominal Wall Evaluated by Dynamic Infrared Thermography (DIRT)
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).
Read the detailed description
Introduction Wound healing problems after surgery are a stressful experience for patients. Wound dressing changes are often on a daily basis and can cause considerable discomfort to the patient as these are often painful. Wound healing problems can lead to complications like wound infection, hernia formation, wound rupture or even tissue necrosis. These complications are often associated with prolonged hospital stays and reoperations and cause an economic burden to the hospital health budget. It is generally accepted that adequate blood perfusion of the wound edges is required for optimal wound healing. Greater understanding of the impact of a surgical procedure on skin perfusion may help to reduce postoperative wound healing problems. Such will have great clinical relevance.
Aim Can postoperative wound complications involving the abdominal wall be explained by changes in skin blood perfusion?
Main results from the literature study In surgery, knowledge on the vascular anatomy is applied in order to place incisions in such a manner that a good approach is combined with minimal damage to the vascular anatomy. Knowledge on vascular anatomy does not provide exact information on how skin perfusion alters after surgery. The invasive method indocyanine green fluorescence-agiography (ICG-FA) can be used to evaluate intraoperatively the effect of an abdominoplasty on skin perfusion. However, animal studies in flap surgery have clearly shown that tissue perfusion is a dynamic process. Using dynamic infrared thermography (DIRT) in a clinical setting revealed that flap perfusion is a dynamic process that takes place over days during the postoperative phase. DIRT is a non-invasive technique that relies on measuring skin surface temperatures. Studies have shown that there is a close correlation between skin temperature and skin perfusion. DIRT has been shown to be a good alternative to ICF-FA to visualize skin perfusion.
Purpose of the study The purpose of the study is to analyze the impact of a surgical procedure on skin perfusion of the abdominal wall in order to increase our understanding on how postoperative wound healing problems can be avoided.
Study population The study population will include patients that are undergoing one of the following operations; a) abdominoplasty, b) breast reconstruction after breast cancer with a free flap from the lower abdomen and c) endovascular stenting of the abdominal aorta for aneurysm. These surgical procedures are frequently performed procedures at the University Hospital of North Norway (UNN). Based on the vascular anatomy of the abdominal wall, each procedure will have an impact on the skin perfusion of the abdominal wall.
Material and Methods Approval will be obtained from the regional ethical committee and the principles outlined in the Declaration of Helsinki will be followed.
Study I The inclusion criteria are patients scheduled for abdominoplasty who are non-smokers or have stopped smoking at least 3 months prior to surgery and have no supraumbilical abdominal scars from previous surgery Study II The inclusion criteria are patients scheduled for secondary unilateral free abdominal flap breast reconstructions who are non-smokers or have stopped smoking at least 3 months prior to surgery and have no abdominal scar from previous surgery.
Study III Patients who are scheduled for endovascular stenting of the abdominal aorta.
DIRT will be performed on the day before surgery, intraoperatively and on the 1st, 3rd and 6th postoperative day with all DIRT examinations performed in the same supine position for study I and II. For study III, the same protocol will be used, however, no intraoperative DIRT examination will be performed. For study III, thermal images are taken from both lower extremities during the abdominal DIRT examination to see if stenting causes a change in rewarming of the lower extremities following stenting.
An IR camera (FLIR ThermaCAM S65 HS FLIR Systems, FLIR Systems AB, Boston, MA) will be positioned directly above the exposed anterior thorax and abdomen. This camera can produce sequences of high-definition digital IR images with an accuracy of 0.1º C. Thermal emissivity is set to 0.98 and the accuracy of the camera will be regularly checked against a black body with a traceable temperature source (Model IR-2103/301, Infrared Systems Development Corp., Florida, USA). IR images are taken at regular intervals to register the rate and pattern of skin recovery for 3 minutes after a mild cold challenge. Images are electronically stored and afterwards processed using image analysis software ThermaCAM Researcher Pro 2.8 SR-1 (FLIR Systems AB).
The pre- and postoperative images are taken in a dedicated laboratory (room temperature 21-23°C) before and during recovery following a cold challenge after an acclimatization period of 10 minutes with the thoracic and abdominal wall exposed. The thermal challenge is delivered by blowing air at room temperature over the skin surface for 2 minutes with a desktop fan. The intraoperative examination is performed with the patient in general anaesthesia just before and at the end of surgery. The thermal cold challenge is performed by washing the thorax and abdomen evenly for 1 minute with gauze soaked in saline at room temperature (22-23°C).
The abdomen is divided into vascular zones as defined by Huger. The mean skin temperature is calculated for each zone in the postoperative phase before cooling, at end cooling and at 1, 2 and 3 minutes recovery. A qualitative analysis of the changes of pattern and rate of recovery of hot spots within each zone is made and compared with the results from the other zones. A one tailed t test for paired variables is use to see if there is a statistically significant in the mean temperatures between zones at each time point of rewarming. Statistical significance is defined as p<0.05.
Publications The results from each study will be published in an international peer-reviewed journal.
- Conditions
- Surgical Wound Infection
- Being tested
- Dynamic infrared thermography (DIRT)
- Keywords
- Surgery, Thermography, Perfusion, Imaging
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic infrared thermography (DIRT)Other
Evaluating abdominal skin perfusion with DIRT
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion dynamics following surgical procedures
DIRT findings on the abdominal wall after three different types of surgery
Measured: First five postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Jan 2013
- Primary completion16 Nov 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis de Weerd, MD PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057249
- Sponsor's protocol ID
- 2012/176
- Acronym
- DIRTSURGERY
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is based on qualitative evaluation of individual thermographic images that are not suitable for public sharing
Publications
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.
PubMed 133628Boltz 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.
PubMed 21676424Broex 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.
PubMed 19482375Hunt TK, Hopf H, Hussain Z. Physiology of wound healing. Adv Skin Wound Care. 2000 May-Jun;13(2 Suppl):6-11.
PubMed 11074996Sen 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.
PubMed 19152646Huger WE Jr. The anatomic rationale for abdominal lipectomy. Am Surg. 1979 Sep;45(9):612-7.
PubMed 159651Mayr 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.
PubMed 15509954Dhar SC, Taylor GI. The delay phenomenon: the story unfolds. Plast Reconstr Surg. 1999 Dec;104(7):2079-91. doi: 10.1097/00006534-199912000-00021.
PubMed 11149772de 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.
PubMed 19131718de 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.
PubMed 21620152
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Selected Surgical Procedure on Skin Blood Perfusion of the Abdominal Wall Evaluated by Dynamic Infrared Thermography (DIRT)
- ClinicalTrials.gov ID
- NCT03057249
- Acronym / sponsor ID
- DIRTSURGERY / 2012/176
- Conditions
- Surgical Wound Infection
- Keywords
- Surgery, Thermography, Perfusion, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Introduction Wound healing problems after surgery are a stressful experience for patients. Wound dressing changes are often on a daily basis and can cause considerable discomfort to the patient as these are often painful. Wound healing problems can lead to complications like wound infection, hernia formation, wound rupture or even tissue necrosis. These complications are often associated with prolonged hospital stays and reoperations and cause an economic burden to the hospital health budget. It is generally accepted that adequate blood perfusion of the wound edges is required for optimal wound healing. Greater understanding of the impact of a surgical procedure on skin perfusion may help to reduce postoperative wound healing problems. Such will have great clinical relevance.
Aim Can postoperative wound complications involving the abdominal wall be explained by changes in skin blood perfusion?
Main results from the literature study In surgery, knowledge on the vascular anatomy is applied in order to place incisions in such a manner that a good approach is combined with minimal damage to the vascular anatomy. Knowledge on vascular anatomy does not provide exact information on how skin perfusion alters after surgery. The invasive method indocyanine green fluorescence-agiography (ICG-FA) can be used to evaluate intraoperatively the effect of an abdominoplasty on skin perfusion. However, animal studies in flap surgery have clearly shown that tissue perfusion is a dynamic process. Using dynamic infrared thermography (DIRT) in a clinical setting revealed that flap perfusion is a dynamic process that takes place over days during the postoperative phase. DIRT is a non-invasive technique that relies on measuring skin surface temperatures. Studies have shown that there is a close correlation between skin temperature and skin perfusion. DIRT has been shown to be a good alternative to ICF-FA to visualize skin perfusion.
Purpose of the study The purpose of the study is to analyze the impact of a surgical procedure on skin perfusion of the abdominal wall in order to increase our understanding on how postoperative wound healing problems can be avoided.
Study population The study population will include patients that are undergoing one of the following operations; a) abdominoplasty, b) breast reconstruction after breast cancer with a free flap from the lower abdomen and c) endovascular stenting of the abdominal aorta for aneurysm. These surgical procedures are frequently performed procedures at the University Hospital of North Norway (UNN). Based on the vascular anatomy of the abdominal wall, each procedure will have an impact on the skin perfusion of the abdominal wall.
Material and Methods Approval will be obtained from the regional ethical committee and the principles outlined in the Declaration of Helsinki will be followed.
Study I The inclusion criteria are patients scheduled for abdominoplasty who are non-smokers or have stopped smoking at least 3 months prior to surgery and have no supraumbilical abdominal scars from previous surgery Study II The inclusion criteria are patients scheduled for secondary unilateral free abdominal flap breast reconstructions who are non-smokers or have stopped smoking at least 3 months prior to surgery and have no abdominal scar from previous surgery.
Study III Patients who are scheduled for endovascular stenting of the abdominal aorta.
DIRT will be performed on the day before surgery, intraoperatively and on the 1st, 3rd and 6th postoperative day with all DIRT examinations performed in the same supine position for study I and II. For study III, the same protocol will be used, however, no intraoperative DIRT examination will be performed. For study III, thermal images are taken from both lower extremities during the abdominal DIRT examination to see if stenting causes a change in rewarming of the lower extremities following stenting.
An IR camera (FLIR ThermaCAM S65 HS FLIR Systems, FLIR Systems AB, Boston, MA) will be positioned directly above the exposed anterior thorax and abdomen. This camera can produce sequences of high-definition digital IR images with an accuracy of 0.1º C. Thermal emissivity is set to 0.98 and the accuracy of the camera will be regularly checked against a black body with a traceable temperature source (Model IR-2103/301, Infrared Systems Development Corp., Florida, USA). IR images are taken at regular intervals to register the rate and pattern of skin recovery for 3 minutes after a mild cold challenge. Images are electronically stored and afterwards processed using image analysis software ThermaCAM Researcher Pro 2.8 SR-1 (FLIR Systems AB).
The pre- and postoperative images are taken in a dedicated laboratory (room temperature 21-23°C) before and during recovery following a cold challenge after an acclimatization period of 10 minutes with the thoracic and abdominal wall exposed. The thermal challenge is delivered by blowing air at room temperature over the skin surface for 2 minutes with a desktop fan. The intraoperative examination is performed with the patient in general anaesthesia just before and at the end of surgery. The thermal cold challenge is performed by washing the thorax and abdomen evenly for 1 minute with gauze soaked in saline at room temperature (22-23°C).
The abdomen is divided into vascular zones as defined by Huger. The mean skin temperature is calculated for each zone in the postoperative phase before cooling, at end cooling and at 1, 2 and 3 minutes recovery. A qualitative analysis of the changes of pattern and rate of recovery of hot spots within each zone is made and compared with the results from the other zones. A one tailed t test for paired variables is use to see if there is a statistically significant in the mean temperatures between zones at each time point of rewarming. Statistical significance is defined as p<0.05.
Publications The results from each study will be published in an international peer-reviewed journal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for 1. Abdominoplasty 2. DIEP breast reconstruction 3. Aorta stenting
Key inclusion criteria (4 listed)
- Patients scheduled for
- Abdominoplasty
- DIEP breast reconstruction
- Aorta stenting
Key exclusion criteria (1 listed)
- Surgery not indicated Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic infrared thermography (DIRT)Evaluating abdominal skin perfusion with DIRT | Other | – |
Primary outcome
Perfusion dynamics following surgical procedures
Time frame: First five postoperative days
DIRT findings on the abdominal wall after three different types of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Results publication: PubMed 133628Nahai 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.
- Results publication: PubMed 21676424Boltz 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.
- Results publication: PubMed 19482375Broex 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.
- Results publication: PubMed 11074996Hunt TK, Hopf H, Hussain Z. Physiology of wound healing. Adv Skin Wound Care. 2000 May-Jun;13(2 Suppl):6-11.
- Results publication: PubMed 19152646Sen 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.
- Results publication: PubMed 159651Huger WE Jr. The anatomic rationale for abdominal lipectomy. Am Surg. 1979 Sep;45(9):612-7.
- Results publication: PubMed 15509954Mayr 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.
- Results publication: PubMed 11149772Dhar SC, Taylor GI. The delay phenomenon: the story unfolds. Plast Reconstr Surg. 1999 Dec;104(7):2079-91. doi: 10.1097/00006534-199912000-00021.
- Results publication: PubMed 19131718de 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.
- Results publication: PubMed 21620152de 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.
- Individual participant dataSharing planned: No. The study is based on qualitative evaluation of individual thermographic images that are not suitable for public sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis de Weerd, MD PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion dynamics following surgical procedures (time frame: First five postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057249, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.