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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03433937
• Other study ID #: S-20170085
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: June 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Lymphedema
• Quality of Life
• Seroma
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Negative pressure wound therapy
Wound dressing

Other:
• Micropore tape
Wound dressing

Locations

Country	Name	City	State
Denmark	Dept. of Plastic Surgery, Herlev Gentofte Hospital	Herlev
Denmark	Dept. of Plastic Surgery, Rigshospitalet	København
Denmark	Dept. of Plastic Surgery, Odense University Hospital	Odense
Denmark	Dept. of Plastic Surgery, Roskilde Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Jørgensen MG, Toyserkani NM, Thomsen JB, Sørensen 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. — View Citation

Outcome

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