Clinical trial NCT03433937: Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Official title: Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Seroma
Surgical Site Infection
Lymphedema
Quality of Life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with seroma
timeFrame: 3 months
Secondary outcomes:
measure: Number of seromas for each participant
timeFrame: 3 months
measure: Volume of seromas for each participant
timeFrame: 3 months
measure: Number of participants with surgical wound infection
timeFrame: 3 months
measure: Number of participants with wound rupture
timeFrame: 3 months
measure: Number of participants with wound necrosis
timeFrame: 3 months
measure: Number of participants with hematoma
timeFrame: 3 months
measure: Questionnaire EQ-5D-5L
timeFrame: Baseline, 3 months and 2 years
measure: Hospitalization time
timeFrame: 3 months
measure: Hospitalization readmission time
timeFrame: 3 months
measure: Number of participants with reoperations
timeFrame: 3 months
measure: Number of participants with lymphedema
timeFrame: 2 years
measure: Questionnaire LYMQOL
timeFrame: 2 years
measure: Number of participants with regional recurrence
timeFrame: 2 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept. of Plastic Surgery, Herlev Gentofte Hospital
city: København
country: Denmark
facility: Dept. of Plastic Surgery, Rigshospitalet
city: Odense
country: Denmark
facility: Dept. of Plastic Surgery, Odense University Hospital
city: Roskilde
country: Denmark
facility: Dept. of Plastic Surgery, Roskilde Hospital
Study officials:
affiliation: Department of Plastic Surgery, Odense University Hospital
name: Jens A Sørensen
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.