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Low inclusion
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Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure wound therapy | Experimental |
| |
| Control | Active Comparator | Micropore tape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure wound therapy | Device | Wound dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with seroma | One or more inguinal seroma(s) which require aspiration | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of seromas for each participant | Number of aspirated seromas (No.) | 3 months |
| Volume of seromas for each participant | Volume of aspirated seromas (mL) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens A Sørensen | Department of Plastic Surgery, Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Plastic Surgery, Rigshospitalet | Copenhagen | Denmark | ||||
| Dept. of Plastic Surgery, Herlev Gentofte Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29246739 | Background | Jorgensen MG, Toyserkani NM, Thomsen JB, Sorensen JA. Surgical-site infection following lymph node excision indicates susceptibility for lymphedema: A retrospective cohort study of malignant melanoma patients. J Plast Reconstr Aesthet Surg. 2018 Apr;71(4):590-596. doi: 10.1016/j.bjps.2017.11.026. Epub 2017 Nov 28. | |
| 36304071 | Derived |
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| Micropore tape | Other | Wound dressing |
|
| 3 months |
| Number of participants with surgical wound infection | Inguinal wound infection which require antibiotic treatment | 3 months |
| Number of participants with wound rupture | Inguinal wound rupture which require addition suturing or NPWT treatment | 3 months |
| Number of participants with wound necrosis | Inguinal wound necrosis which require debridement | 3 months |
| Number of participants with hematoma | Inguinal wound hematoma which require evacuation | 3 months |
| Questionnaire EQ-5D-5L | Quality of life measurement score | Baseline, 3 months and 2 years |
| Hospitalization time | Length of hospital stay until discharge (days) | 3 months |
| Hospitalization readmission time | Length of hospital readmissions (days) | 3 months |
| Number of participants with reoperations | Re-operation with opening of the wound or scar under general anesthesia due to adverse complications | 3 months |
| Number of participants with lymphedema | Clinical evaluation using the International Lymphedema Society staging | 2 years |
| Questionnaire LYMQOL | Lymphedema quality of life measurement score | 2 years |
| Number of participants with regional recurrence | Histological verified recurrence to the inguinal site | 2 years |
| Herlev |
| Denmark |
| Dept. of Plastic Surgery, Odense University Hospital | Odense | Denmark |
| Dept. of Plastic Surgery, Roskilde Hospital | Roskilde | Denmark |
| Jorgensen MG, Chakera AH, Holmich LR, Drejoe JB, Andersen PCL, Khorasani H, Toyserkani NM, Thomsen JB, Sorensen JA. Can prophylactic incisional negative pressure wound therapy Reduce Wound Complications After Inguinal Lymph Node Dissection for Melanoma? Results from a Randomized Controlled Trial. JPRAS Open. 2022 Aug 26;34:134-143. doi: 10.1016/j.jpra.2022.08.003. eCollection 2022 Dec. |
| 30111378 | Derived | Jorgensen MG, Toyserkani NM, Hyldig N, Chakera AH, Holmich LR, Thomsen JB, Sorensen JA. Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial. Trials. 2018 Aug 15;19(1):441. doi: 10.1186/s13063-018-2757-6. |
| ID | Term |
|---|---|
| D049291 | Seroma |
| D013530 | Surgical Wound Infection |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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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