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

被引：7
作者：
Jorgensen, Mads Gustaf [1 ]
Toyserkani, Navid Mohammadpour [1 ,4 ]
Hyldig, Nana [2 ]
Chakera, Annette Hougaard [3 ]
Holmich, Lisbet Rosenkrantz [3 ]
Thomsen, Jorn Bo [1 ]
Sorensen, Jens Ahm [1 ]
机构：
[1] Odense Univ Hosp, Dept Plast Surg, Sdr Blvd 29, DK-5000 Odense, Denmark
[2] Odense Univ Hosp, Hans Christian Andersens Children Hosp, Odense, Denmark
[3] Herlev Gentofte Hosp, Dept Plast Surg, Herlev, Denmark
[4] Roskilde Hosp, Dept Plast Surg, Roskilde, Denmark
来源：
TRIALS | 2018年 / 19卷
关键词：
Prevention; Negative-pressure wound therapy; Seroma; Surgical-site infection; Lymphedema; Lymph node dissection; Melanoma;
D O I：
10.1186/s13063-018-2757-6
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
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.
引用
收藏
页数：8
相关论文
共 26 条
  • [1] Siegel R.L., Miller K.D., Jemal A., Cancer statistics, 2017, CA Cancer J Clin, 67, 1, pp. 7-30, (2017)
  • [2] Faries M.B., Thompson J.F., Cochran A.J., Et al., Completion dissection or observation for sentinel-node metastasis in melanoma, N Engl J Med, 376, 23, pp. 2211-2222, (2017)
  • [3] Jorgensen M.G., Toyserkani N.M., Thomsen J.B., Sorensen J.A., Surgical-site infection following lymph node excision indicates susceptibility for lymphedema: A retrospective cohort study of malignant melanoma patients, J Plast Reconstr Aesthet Surg, 71, 4, pp. 590-596, (2018)
  • [4] Chang S.B., Askew R.L., Xing Y., Et al., Prospective assessment of postoperative complications and associated costs following inguinal lymph node dissection (ILND) in melanoma patients, Ann Surg Oncol, 17, 10, pp. 2764-2772, (2010)
  • [5] Agrawal A., Ayantunde A.A., Cheung K.L., Concepts of seroma formation and prevention in breast cancer surgery, ANZ J Surg, 76, 12, pp. 1088-1095, (2006)
  • [6] Hjort A., Gottrup F., Cost of wound treatment to increase significantly in Denmark over the next decade, J Wound Care, 19, 5, pp. 173-174, (2010)
  • [7] Posnett J., Gottrup F., Lundgren H., Saal G., The resource impact of wounds on health-care providers in Europe, J Wound Care, 18, 4, pp. 154-161, (2009)
  • [8] Ul-Mulk J., Holmich L.R., Lymph node dissection in patients with malignant melanoma is associated with high risk of morbidity, Dan Med J, 59, 6, (2012)
  • [9] Argenta L.C., Morykwas M.J., Vacuum-assisted closure: a new method for wound control and treatment: clinical experience, Ann Plast Surg, 38, 6, pp. 563-576, (1997)
  • [10] Borgquist O., Ingemansson R., Malmsjo M., The influence of low and high pressure levels during negative-pressure wound therapy on wound contraction and fluid evacuation, Plast Reconstr Surg, 127, 2, pp. 551-559, (2011)
123