Background Primary closure of the fascia at the conclusion of a stage laparotomy can be a challenging task. Current techniques to medialize the fascial edges in open abdomens entail several trips to the operating room and could result in fascial damage. We conducted a pilot study to investigate a novel non-invasive device for gradual reapproximation of the abdominal wall fascia in the open abdomen.
Methods Mechanically ventilated patients ≥16 years of age with the abdominal fascia deliberately left open after a midline laparotomy for trauma and acute care surgery were randomized into two groups. Control group patients underwent standard care with negative pressure therapy only. Device group patients were treated with negative pressure therapy in conjunction with the new device for fascial reapproximation. Exclusion criteria: pregnancy, traumatic hernias, pre-existing ventral hernias, burns, and body mass index ≥40 kg/m2. The primary outcome was successful fascial closure by direct suture of the fascia without mesh or component separation. Secondary outcomes were abdominal wall complications.
Results Thirty-eight patients were investigated, 20 in the device group and 18 in the control group. Primary closure of the fascia by direct suture without mesh or component separation was achieved in 17 patients (85%) in the device group and only 10 patients (55.6%) in the control group (p=0.0457). Device group patients were 53% more likely to experience primary fascial closure by direct suture than control group patients. Device group showed gradual reduction (p<0.005) in the size of the fascial defects; not seen in control group. There were no complications related to the device.
Conclusions The new device applied externally on the abdominal wall promoted reapproximation of the fascia in the midline, preserved the integrity of the fascia, and improved primary fascial closure rate compared with negative pressure therapy system only.
Level of evidence I, randomized controlled trial.
- abdominal injuries
- randomized controlled trial
- wound closure techniques
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Contributors JBRN: devised the technology, conceived the study (principal investigator), data interpretation and led the elaboration of the article, literature search, and critical revision. BGC: data acquisition, data interpretation, literature search, contributed to the elaboration of the article.
Funding This study was supported by the Canadian Institutes of Health Research (CIHR)–Proof of Principle Program–Phase 1 Grant (201502PPP-345409-PPP-CEAJ-259794).
Competing interests JBRN (corresponding author of the article) was the inventor of the device used in the study and holds a patent on the device (PCT/CA2016/050124).
Patient consent for publication Not required.
Ethics approval This study was approved by St Michael’s Hospital Research Ethics Board under protocol number REB14-314.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.