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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
| University of Southern Denmark | OTHER |
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The purpose of the study is to examine whether incision type has an influence on the development of groin wound complications after operation in the groin in vascular surgery.
The main questions it aims to answer are:
Does a transverse incision in the groin lead to fewer surgical site complications than a longitudinal incision? Does a transverse incision lead to fewer readmissions, fewer reoperations, shorter length of hospital stay, and a lower amputation rate.
Participants will undergo vascular surgery in the groin with either a transverse or longitudinal incision. The incision type will be selected randomly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transverse groin incision | Experimental |
| |
| Longitudinal groin incision | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transverse groin incision | Procedure | The transverse incision is made parallel to the inguinal ligament either superiorly or inferiorly to the skin crease directly over the femoral artery. The subcutaneous tissue is dissected in the transverse direction till Scarpaes fascia after which the dissection is performed in the longitudinal direction along the line of the vessels. The lymphatic vessels are spared as much as possible. Any damaged lymph vessels are closed with surgical clips. Damages lymph nodes are either removed or the capsule is sutured to prevent lymph leakage. In case of difficulty with proper access to the femoral arteries, the incision can be extended either medially, laterally, or vertically. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgical site complications | The surgical site complications are defined as follows:
| 35 days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation | Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation | 35 days after the operation |
| Readmission | Is the patient readmitted due to either surgical site complications or for other reasons |
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Inclusion Criteria:
• Patients undergoing vascular reconstruction with a groin incision
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina P Madsen, Dr | Contact | +4576360788 | christina.pilgaard.madsen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kim Trine Maria Mejnert Jørgensen, MD, PhD | Department of vascular surgery, Kolding Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery - Lillebaelt Hospital | Recruiting | Kolding | 6000 | Denmark |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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The trial is a single center superiority randomized clinical trial with two parallel groups with 1:1 randomization to either transverse or longitudinal incision in the groin in vascular surgery with arterial reconstruction.
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|
| Longitudinal incision | Procedure | The longitudinal incision is made directly over the femoral artery from the inguinal ligament. The subcutaneous tissue is dissected along the line of the vessel sparing the lymphatic vessels as much as possible. Any damaged lymph vessels are closed with clips. Damages lymph nodes are either removed or the capsule is sutured to prevent lymph leakage. |
|
| 35 days |
| • Length of stay | The duration of the hospital stay after the operation. | 35 days |
| Mortality | Death and the cause of death. | 35 days |
| Healing of the groin | Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications. | 35 days |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D014947 | Wounds and Injuries |