Clinical trial · Interventional
Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients
Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients: A Prospective Randomized Trial of Two Approaches to Wound Drainage
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective randomized non-inferiority study is designed to compare the rate and severity of complications after axillary and inguinal lymph node dissection in stage III melanoma patients in a study group where the drain is left in place for three weeks and a control group consisting of patients managed according to the standard institutional protocol. Furthermore, variables associated with complications will be examined.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complication | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Suction drain | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study group
- description
- Wound drain is kept until until a scheduled visit three weeks after the surgery unless the drain produced less than 30 ml/day for two consecutive days, in which case it could be removed earlier.
- interventionNames
- Procedure: Suction drain
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- When the drain produces less than 100 mL over 24 hours, the self-suction bulb is removed and the drain is shortened and drained into a colostomy bag placed around the site of drain insertion. A request is filed with the community nursing system to have a visiting nurse to pull out the drain 1-2 cm per day.
- interventionNames
- Procedure: Suction drain
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * stage III melanoma patients with confirmed metastases to lymph nodes in axilla or groin Exclusion Criteria: * unable to follow instructions or provide an informed written consent
References
Publications (0)
Data not yet available