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

Lisbet Rosenkrantz Hölmich¹  Annette Hougaard Chakera¹  Jens Ahm Sørensen²  Navid Mohamadpour Toyserkani²  Mads Gustaf Jørgensen²  Jørn Bo Thomsen²  Nana Hyldig³ 

[1] Department of Plastic Surgery, Herlev Gentofte Hospital;Department of Plastic Surgery, Odense University Hospital;Hans Christian Andersen’s Children Hospital, Odense University Hospital;

关键词: Prevention;    Negative-pressure wound therapy;    Seroma;    Surgical-site infection;    Lymphedema;    Lymph node dissection;   

DOI  :  10.1186/s13063-018-2757-6

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown