TY - JOUR

T1 - Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial)

T2 - study protocol for a randomized controlled trial

AU - Gustaf Jørgensen, Mads

AU - Toyserkani, Navid Mohamadpour

AU - Hyldig, Nana

AU - Chakera, Annette Hougaard

AU - Hölmich, Lisbet Rosenkrantz

AU - Thomsen, Jørn Bo

AU - Sørensen, Jens Ahm

PY - 2018

Y1 - 2018

N2 - BACKGROUND: Radical inguinal lymphadenectomy (ILND) for metastatic melanoma is associated with a high complication rate. Seroma is often the first postoperative complication, followed by prolonged wound healing sometimes requiring reoperation, infection, multiple outpatient visits and re-hospitalization. Prevention of seroma may, therefore, lead to a reduction in many of the other complications.METHODS/DESIGN: The primary aim of this randomized study is to investigate whether fewer patients require treatment for seroma by immediate prophylactic application of incisional, Negative-pressure Wound Therapy (iNPWT) following ILND, compared to standard postoperative treatment. The secondary outcomes include surgical-site infection, dehiscence, hematoma, length of hospitalization, quality of life, safety, long-term assessment of lymphedema and non-inferiority oncological outcome. Data will be registered prospectively at check-ups after 7 and 14 days, 1 and 3 months and 2 years after inguinal lymphadenectomy using case report forms and questionnaires and stored in a secure online database.DISCUSSION: To our knowledge, this trial is the first randomized study evaluating negative-pressure wound therapy as a prophylactic intervention for complications following melanoma-related ILND. The results from this trial will hopefully determine the efficacy and safety of prophylactic iNPWT treatment in prevention of the clinical relevant short- and long-term postoperative complications following ILND and may provide an evidence base for the an improved postoperative regimen.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03433937 . Prospectively registered on 15 February 2018.

AB - BACKGROUND: Radical inguinal lymphadenectomy (ILND) for metastatic melanoma is associated with a high complication rate. Seroma is often the first postoperative complication, followed by prolonged wound healing sometimes requiring reoperation, infection, multiple outpatient visits and re-hospitalization. Prevention of seroma may, therefore, lead to a reduction in many of the other complications.METHODS/DESIGN: The primary aim of this randomized study is to investigate whether fewer patients require treatment for seroma by immediate prophylactic application of incisional, Negative-pressure Wound Therapy (iNPWT) following ILND, compared to standard postoperative treatment. The secondary outcomes include surgical-site infection, dehiscence, hematoma, length of hospitalization, quality of life, safety, long-term assessment of lymphedema and non-inferiority oncological outcome. Data will be registered prospectively at check-ups after 7 and 14 days, 1 and 3 months and 2 years after inguinal lymphadenectomy using case report forms and questionnaires and stored in a secure online database.DISCUSSION: To our knowledge, this trial is the first randomized study evaluating negative-pressure wound therapy as a prophylactic intervention for complications following melanoma-related ILND. The results from this trial will hopefully determine the efficacy and safety of prophylactic iNPWT treatment in prevention of the clinical relevant short- and long-term postoperative complications following ILND and may provide an evidence base for the an improved postoperative regimen.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03433937 . Prospectively registered on 15 February 2018.

KW - Clinical Protocols

KW - Denmark

KW - Humans

KW - Lymph Node Excision/adverse effects

KW - Lymphatic Metastasis

KW - Melanoma/secondary

KW - Negative-Pressure Wound Therapy/adverse effects

KW - Prospective Studies

KW - Research Design

KW - Seroma/diagnosis

KW - Skin Neoplasms/pathology

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s13063-018-2757-6

DO - 10.1186/s13063-018-2757-6

M3 - Journal article

C2 - 30111378

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 441

ER -