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Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed.
Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates.
Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique.
Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction | Other | Incisional hernia incidence for patients treated with Vacuum Assisted Wound Closure and Permanent On-lay Mesh mediated fascial traction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) | Procedure | Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen. |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia at 1 year | Incidence of incisional hernia after open abdomen closure with the technique | 1 year, year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Fascial closure rate | Percentage of patients possible to closed with the technique | During hospital stay |
| Complications | Complications related to the technique |
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Inclusion Criteria:
• All patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulf Pettersson, Ass prof | Contact | +46705657446 | ulf.a.petersson@telia.com | |
| Peder Rogmark, MD, PhD | Contact | +46 40 333398 | peder.rogmark@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Ulf Pettersson, Ass prof | Lund University, Sweden. Department of Surgery Skane university hospital, Sweden | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30574843 | Background | Petersson P, Montgomery A, Petersson U. Vacuum-Assisted Wound Closure and Permanent Onlay Mesh-Mediated Fascial Traction: A Novel Technique for the Prevention of Incisional Hernia after Open Abdomen Therapy Including Results From a Retrospective Case Series. Scand J Surg. 2019 Sep;108(3):216-226. doi: 10.1177/1457496918818979. Epub 2018 Dec 21. |
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| Up to 12 weeks |
| Incisional hernia | Incisional hernia incidence after three years | Through study completion, 3 years |
| EQ5D | Patient reported outcome of generic quality of life | Through study completion, 3 years |
| HERO | Patient reported outcome of abdominal wall function and discomfort | Through study completion, 3 years |
| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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