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| Name | Class |
|---|---|
| Aesculap AG | INDUSTRY |
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A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Stitch | Short stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Stitch | Procedure | MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification | until discharge (ca. 10 days after operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation rate due to burst abdomen until discharge | until discharge (ca. 10 days after operation) | |
| Wound healing complications until discharge | until discharge (ca. 10 days after operation) | |
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Inclusion Criteria:
Exclusion Criteria:
- Pregnant women
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Markus Golling, Prof. | Diakonie-Klinikum Schwäbisch Hall gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakonie Klinikum Schwäbisch Hall gGmbH | Schwäbisch Hall | 74523 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Golling M, Breul V, Zielska Z et al. 6:1 Suture or Wound length ratio with the short stitch technique - a reality check on practicability and short term outcome. Sur Res J. 2022;2(2). | ||
| 38285168 | Result | Golling M, Breul V, Zielska Z, Baumann P. The 6:1 short stitch SL-WL-ratio: short term closure results of transverse and midline incisions in elective and emergency operations. Hernia. 2024 Apr;28(2):447-456. doi: 10.1007/s10029-023-02927-4. Epub 2024 Jan 29. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| Length of postoperative hospital stay |
| until discharge (ca. 10 days after operation) |
| Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down) | intraoperative |
| D013568 |
| Pathological Conditions, Signs and Symptoms |