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


Jørgensen, Mads Gustaf; Toyserkani, Navid Mohamadpour; Hyldig, Nana; Chakera, Annette Hougaard; Hölmich, Lisbet Rosenkrantz; Thomsen, Jørn Bo; Sørensen, Jens Ahm (2018). 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, 19(1):441.

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.

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.

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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Radiation Oncology
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Medicine (miscellaneous)
Health Sciences > Pharmacology (medical)
Language:English
Date:19 October 2018
Deposited On:23 Jan 2019 15:16
Last Modified:11 May 2020 18:22
Publisher:BioMed Central
ISSN:1745-6215
Additional Information:Korrekturartikel: https://doi.org/10.1186/s13063-018-2882-2
OA Status:Gold
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1186/s13063-018-2757-6
PubMed ID:30111378

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