Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy

Not Applicable

Terminated

• Conditions: Lymphedema; Surgical Site Infection; Quality of Life; Seroma
• Interventions: Other: Micropore tape; Device: Negative pressure wound therapy

• Registration Number: NCT03433937
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Study Start: 2018-04-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• All malignant melanoma patients who are candidates for ILND and 18 years of age or older

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Exclusion Criteria

• Patients suspected of having tumor residuals after ILND, previous groin irradiation or patients suffering from dementia or any psychiatric disorder making them incapable of informed consent or adherence to follow up, along with patients who are unable to communicate in Danish or English will not be included in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Micropore tape	Micropore tape
Negative pressure wound therapy	Negative pressure wound therapy	-

Primary Outcome Measures

Name	Time	Method
Number of participants with seroma	3 months	One or more inguinal seroma(s) which require aspiration

Secondary Outcome Measures

Name	Time	Method
Number of seromas for each participant	3 months	Number of aspirated seromas (No.)
Number of participants with surgical wound infection	3 months	Inguinal wound infection which require antibiotic treatment
Number of participants with wound necrosis	3 months	Inguinal wound necrosis which require debridement
Hospitalization readmission time	3 months	Length of hospital readmissions (days)
Questionnaire LYMQOL	2 years	Lymphedema quality of life measurement score
Volume of seromas for each participant	3 months	Volume of aspirated seromas (mL)
Number of participants with wound rupture	3 months	Inguinal wound rupture which require addition suturing or NPWT treatment
Questionnaire EQ-5D-5L	Baseline, 3 months and 2 years	Quality of life measurement score
Number of participants with lymphedema	2 years	Clinical evaluation using the International Lymphedema Society staging
Number of participants with regional recurrence	2 years	Histological verified recurrence to the inguinal site
Number of participants with hematoma	3 months	Inguinal wound hematoma which require evacuation
Hospitalization time	3 months	Length of hospital stay until discharge (days)
Number of participants with reoperations	3 months	Re-operation with opening of the wound or scar under general anesthesia due to adverse complications

Trial Locations

Locations (4)

Dept. of Plastic Surgery, Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Dept. of Plastic Surgery, Herlev Gentofte Hospital; 🇩🇰 Herlev, Denmark

Dept. of Plastic Surgery, Odense University Hospital; 🇩🇰 Odense, Denmark

Dept. of Plastic Surgery, Rigshospitalet; 🇩🇰 København, Denmark