Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial

Abstract

BackgroundRadical 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/designThe 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.DiscussionTo 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 registrationClinicalTrials.gov, ID: NCT03433937. Prospectively registered on 15 February 2018.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2757-6) contains supplementary material, which is available to authorized users.

Can prophylactic incisional negative pressure wound therapy Reduce Wound Complications After Inguinal Lymph Node Dissection for Melanoma? Results from a Randomized Controlled Trial

“…This prospective multicenter, randomized (1:1), open-labeled, parallel-group study was conducted in Denmark (four sites); at the Departments of Plastic Surgery at Odense University Hospital, Herlev Gentofte Hospital, Rigshospitalet, and Roskilde Hospital. The trial results herein were reported following the published trial protocol and the Consolidated Standards of Reporting Trials (CONSORT) statement 13 , 14 . All study data were collected and managed using REDCap (Research Electronic Data Capture) electronic data capture tools hosted at Odense University Hospital 15 , 16 .…”

“…It was initially planned to include 110 patients over a 3-year timeframe 13 . However, shortly before the trial was initiated, complete lymph node dissection was no longer performed routinely for micrometastatic disease in Denmark following the MSLT-II and DeCOG trial results 5 , 6 , 12 .…”

“…The ILND was performed as a standard lymph node dissection where all lymph nodes and adipose tissue were excised in the triangular region delineated by the sartorius muscle, adductor longus muscle, and the inguinal ligament, with clearance of the adjacent lower abdominal wall, up until approximately 5 cm above the inguinal ligament 13 . The wound was then closed using a 3.0 resorbable and a 4.0 non-resorbable suture and covered with an iNPWT dressing or Micropore™ tape, depending on treatment allocation.…”

Correction to: Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial

“…Following publication of the original article [ 1 ], the authors reported that one of the authors’ names is spelled incorrectly. In this Correction the incorrect and correct author name are shown.…”

The Role of Portable Incisional Negative Pressure Wound Therapy (piNPWT) in Reducing Local Complications of Post-bariatric Brachioplasty: A Case-Control Study

“…At present, the piNPWT has been shown effective in improving wound healing in several surgical fields, reducing at the same time risks of complications even in other surgeries: inguinal dissection [17], mastectomy [18], ALT flap donor site [19], cesarean sections in highrisk patients [20,21]. Benefits from the piNPWT application have been reported in a case-control study in postbariatric abdominoplasty [21] and in cost-utility analysis [22].…”