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 - 2018/8/15
Y1 - 2018/8/15
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.
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.
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
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
M1 - 441
ER -