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Assessment of a Device for Standardized Laparotomy Closure

Petersson Börner, Peter Gabriel Magnus LU (2025) In Lund University, Faculty of Medicine Doctoral Dissertation Series
Abstract
Introduction
Common complications after surgical procedures include surgical site infection, wound rupture and incisional hernia. Wound healing can be influenced by the technique for abdominal access and closure.
A Suture-Length to Wound-Length (SL/WLr) ratio ≥ 4 is advised to achieve a high-quality wound closure. This thesis describes the background and clinical realities of abdominal wall related complications as well as the development process and results from the evaluation of a novel device for standardized laparotomy closure. The aim was to assess the device from a technical, clinical and a health economy perspective.

Method
SutureTOOL is a handheld single use suture applicator with the purpose of... (More)
Introduction
Common complications after surgical procedures include surgical site infection, wound rupture and incisional hernia. Wound healing can be influenced by the technique for abdominal access and closure.
A Suture-Length to Wound-Length (SL/WLr) ratio ≥ 4 is advised to achieve a high-quality wound closure. This thesis describes the background and clinical realities of abdominal wall related complications as well as the development process and results from the evaluation of a novel device for standardized laparotomy closure. The aim was to assess the device from a technical, clinical and a health economy perspective.

Method
SutureTOOL is a handheld single use suture applicator with the purpose of facilitating best practise for wound closure by applying a to SL/WLr ≥ 4. It was developed by the author and a MedTech team associated with Lund University and evaluated in experimental, clinical and health economy models.
Study I: Ten surgeons performed incision closures on an elk fascia model comparing SutureTOOL to NDS concerning adherence to SL/WLr 4. This was achieved in 98% for SutureTOOL and 30% for NDS. Closure time was 30% shorter when using the SutureTOOL.
Study II: Fifteen surgeons performed incision fascial closures comparing Suture TOOL to NDS in a human autopsy model. Adherence to SL/WLr of 4 was 95% for SutureTOOL and 69% for NDS. Closure time was 30% shorter when using the SutureTOOL.
Study III: Twenty-five surgeons and ten nurses performed needle pull-throughs in an incisional lamb leather model comparing SutureTOOL and two different sizes of curved suture needles for needle pull-through time, medial traction and forceps force. SutureTOOL was faster and resulted in less forceps
force.
Study IV: Five colorectal surgeons performed laparotomy closures with SutureTOOL in a single arm study on 38 colorectal patients. The primary endpoint was adherence to SL/WLr of ≥4. Secondary endpoints included closure time and surgical site infections. All patients received a SL/WLr of at least 4.
Mean closure time was 7.4 min and the shortest closure time was 2.2 min. One SSI was detected and no patient suffered from wound dehiscence.
Study V: The aim of the study was to compare the economic and clinical outcomes of laparotomy closure for patients using manual needle-driver suturing compared to SutureTOOL from a healthcare perspective in Sweden, France, UK and US. A decision tree model was developed to implement the analysis. The SutureTOOL was found to be cost-effective, reducing costs between 22% and 40% across country contexts. Savings were associated with reduced post-operative complications and reductions in operating room time.

Conclusion: Wound infection and incisional hernia are common complications to abdominal surgery. These complications can be reduced by adhering to a standardized high quality closure technique. However, even though guidelines exist, they have been difficult to implement in clinical practice. The thesis showed a high adherence to SL/WLr of 4 for SutureTOOL, performed with consistent quality and faster compared to needle-driver suturing. Suture-TOOL has the potential to reduce wound complications and would be a cost-effective intervention. (Less)
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author
supervisor
opponent
  • Clinical Associate Professor Helgstrand, Fredrik, Clinical Associate Professor, Department of Clinical Medicine, University of Copenhagen
organization
publishing date
type
Thesis
publication status
published
subject
in
Lund University, Faculty of Medicine Doctoral Dissertation Series
issue
2025-106
pages
94 pages
publisher
Lund University, Faculty of Medicine
defense location
Medicinhistoriska muséet, Bergaliden 20, Helsingborg
defense date
2025-10-03 13:00:00
ISSN
1652-8220
ISBN
978-91-8021-759-0
language
English
LU publication?
yes
id
009fb2c8-b06d-4fbe-824c-10034507a5a2
date added to LUP
2025-09-03 15:25:24
date last changed
2025-09-09 11:47:31
@phdthesis{009fb2c8-b06d-4fbe-824c-10034507a5a2,
  abstract     = {{Introduction <br/>Common complications after surgical procedures include surgical site infection, wound rupture and incisional hernia. Wound healing can be influenced by the technique for abdominal access  and closure. <br/>A Suture-Length to Wound-Length (SL/WLr) ratio ≥ 4 is advised to achieve a high-quality wound closure. This thesis describes the background and clinical realities of abdominal wall related complications as well as the development process and results from the evaluation of a novel device for standardized laparotomy closure. The aim was to assess the device from a technical, clinical and a health economy perspective.  <br/><br/>Method <br/>SutureTOOL is a handheld single use suture applicator with the purpose of facilitating best practise for wound closure by applying a to SL/WLr ≥ 4. It was developed by the author and a MedTech team associated with Lund University and evaluated in experimental, clinical and health economy models.  <br/>Study I: Ten surgeons performed incision closures on an elk fascia model comparing SutureTOOL to NDS concerning adherence to SL/WLr 4. This was achieved in 98% for SutureTOOL and 30% for NDS. Closure time was 30% shorter when using the SutureTOOL.  <br/>Study II: Fifteen surgeons performed incision fascial closures comparing Suture TOOL to NDS in a human autopsy model. Adherence to SL/WLr of 4 was 95% for SutureTOOL and 69% for NDS. Closure time was 30% shorter when using the SutureTOOL. <br/>Study III: Twenty-five surgeons and ten nurses performed needle pull-throughs in an incisional lamb leather model comparing SutureTOOL and two different sizes of curved suture needles for needle pull-through time, medial traction and forceps force. SutureTOOL was faster and resulted in less forceps <br/>force. <br/>Study IV: Five colorectal surgeons performed laparotomy closures with SutureTOOL in a single arm study on 38 colorectal patients. The primary endpoint was adherence to SL/WLr of ≥4. Secondary endpoints included closure time and surgical site infections. All patients received a SL/WLr of at least 4. <br/>Mean closure time was 7.4 min and the shortest closure time was 2.2 min. One SSI was detected and no patient suffered from wound dehiscence.  <br/>Study V: The aim of the study was to compare the economic and clinical outcomes of laparotomy closure for patients using manual needle-driver suturing compared to SutureTOOL from a healthcare perspective in Sweden, France, UK and US. A decision tree model was developed to implement the analysis. The SutureTOOL was found to be cost-effective, reducing costs between 22% and 40% across country contexts. Savings were associated with reduced post-operative complications and reductions in operating room time.  <br/><br/>Conclusion: Wound infection and incisional hernia are common complications to abdominal surgery. These complications can be reduced by adhering to a standardized high quality closure technique. However, even though guidelines exist, they have been difficult to implement in clinical practice. The thesis showed a high adherence to SL/WLr of 4 for SutureTOOL, performed with consistent quality and faster compared to needle-driver suturing. Suture-TOOL has the potential to reduce wound complications and would be a cost-effective intervention.}},
  author       = {{Petersson Börner, Peter Gabriel Magnus}},
  isbn         = {{978-91-8021-759-0}},
  issn         = {{1652-8220}},
  language     = {{eng}},
  number       = {{2025-106}},
  publisher    = {{Lund University, Faculty of Medicine}},
  school       = {{Lund University}},
  series       = {{Lund University, Faculty of Medicine Doctoral Dissertation Series}},
  title        = {{Assessment of a Device for  Standardized Laparotomy Closure}},
  url          = {{https://lup.lub.lu.se/search/files/226966684/Assessment_of_a_Device_for_Standardized_Laparotomy_Closure_online_250903.pdf}},
  year         = {{2025}},
}