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Randomized Controlled Trial
. 2018 Aug 15;19(1):441.
doi: 10.1186/s13063-018-2757-6.

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

Mads Gustaf Jørgensen  1 , Navid Mohamadpour Toyserkani  1   2 , Nana Hyldig  3 , Annette Hougaard Chakera  4 , Lisbet Rosenkrantz Hölmich  4 , Jørn Bo Thomsen  1 , Jens Ahm Sørensen  5
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Randomized Controlled Trial

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

Mads Gustaf Jørgensen et al. Trials. .

Erratum in

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.

Keywords: Lymph node dissection; Lymphedema; Melanoma; Negative-pressure wound therapy; Prevention; Seroma; Surgical-site infection.

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Conflict of interest statement

Ethics approval and consent to participate

The trial has been approved by The Regional Committees on Health Research Ethics (S-20170085) and registered with the Danish Data Protection Agency (2008–58-0018). Informed consent will be obtained from all participants in the study.

Consent for publication

Not applicable

Competing interests

NH has been paid for providing presentations for Smith&Nephew.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Screening, treatment and follow-up algorithm. Overview of the trial process
Fig. 2
Fig. 2
Participant timelines
See this image and copyright information in PMC

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