This study reported the morbidity rates in the largest series of non-metastatic melanoma patients in Italy and one of the largest series worldwide. The present work allowed to evaluate standardization and quality of surgical treatment of cutaneous melanoma within the frame of the Italian Melanoma Intergroup, which is the largest Italian scientific organization dedicated to the management of patients with this disease (10).
The occurrence of wound dehiscence and seroma after SLNB or LFND were in broad agreement with previous studies (13–15) (Table 1), thus suggesting limited opportunities for further improvements now. Such rates can be used as morbidity benchmarks in addition to avaialble quality indicators for surgical treatment of melanoma (10).
Table 1
Referral values for morbidity rate in the IMI-CNMR study and in the international literature.
Surgical | Indicators | Benchmark referral values |
Procedure | | Present study | International literature |
WE | Wound infection | 1.1% (0.4–2.7%) | 4.6–8.4% a |
Wound dehiscence | 2.0% (0.8–5.1%) | 3.5–4.6% a |
Skin graft failure | unreliable | < 2% a |
SLNB | Wound Infection | 1.3% (0.7–2.5%) | 2.9% (1.5–4.6%) b |
Wound dehiscence | 0.9% (0.2–3.0%) | 0.24–1.2% a |
Seroma | 4.2% (1.5–11.1%) | 5.1% (2.5–8.6%) b |
LFND | Wound infection | 4.1% (2.1–8.0%) | 15.8% a |
Wound dehiscence | 2.8% (0.9–8.6%) | 3% a |
Wound infection and/or dehiscence | 6.5% (2.9–14.0%) | 21.6% (13.8–30.6%) c |
Seroma | 15.1% (4.6–39.9%) | 17.9% (10.3–27%) c |
Data expressed as percentage with 95% confidence interval in parentheses. |
a Morton DL, Cochran AJ, Thompson JF, Elashoff R, Essner R, Glass EC, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Wang HJ; Multicenter Selective Lymphadenectomy Trial Group. Sentinel node biopsy for early-stage melanoma: accuracy and morbidity in MSLT-I, an international multicenter trial. Ann Surg. 2005 Sep;242(3):302 − 11; discussion 311-3. |
b Moody JA, Ali RF, Carbone AC, Singh S, Hardwicke JT. Complications of sentinel lymph node biopsy for melanoma - A systematic review of the literature. Eur J Surg Oncol. 2017;43:270–277. |
c Moody JA, Botham SJ, Dahill KE, Wallace DL, Hardwicke JT. Complications following completion lymphadenectomy versus therapeutic lymphadenectomy for melanoma - A systematic review of the literature. Eur J Surg Oncol. 2017;43:1760–1767. |
Supplementary Fig. 1. Flow-chart of patient inclusion in wide excision (WE) analysis |
Interestingly, we found lower occurrence of wound infection after WE or LFND when compared to available literature (13) (Table 1). On one hand, this difference might be partially due to different definitions of wound infection, i.e. presence of fever, only skin redness, suppuration versus cellulitis, isolation of bacteria from wound. On the other hand, some factors might have led to such difference, including: i) recording of infections occurring only during hospital stay or also at the time of outpatient department visits; ii) different frequency/type of antibiotic prophylaxis; iii) different surgical techniques (i.e., use, type and duration of permanence of drainages in the surgical wound).
Postoperative infections account for around one out of four complications associated with hospital-related health care procedures, and can impair patient prognosis (17). Beyond clinical importance, a low infection rate can also have an economic impact, since the management of hospital-related infections requires about 0.8% of gross domestic product (GDP) in Italy (18).
Unfortunately, the information on skin graft failure was not reliable because one out of five forms did not report such complication. This situation likely occurred because skin graft failure required a reconstructive surgical management that several centers demanded to a different surgical unit. This situation may be addressed by improving the information exchange among surgical centers involved in patient care.
Of note, morbidity rates showed high heterogeneity across melanoma centers, underlying the role of the center itself on this matter. Our data suggested an association between higher morbidity rate and small-volume centers, thus confirming the relationship between patient outcome and hospital surgical volume (16).
The present study contribute to the definition of quality indicators for surgical treatment for non-metastatic skin melanoma, by adding morbidity indicators that can be used as the basis for a standardized quality assurance program (10). The importance of this topic relies on the large number of surgical procedures for non-metastatic skin melanoma (2), thus patient management and prognosis can benefit from quality control and standardization of such procedures (4, 5).
The strengths of this study included the prospective collection of data in a national registry, the multicenter design and the standardized definitions of the complications (11). The study has some limitations. First, a considerable number of centers were excluded due to poor completeness of data. Although this approach allowed limiting the impact of low-quality data on the study results, the representativeness of the included centers may be limited. Future developments will aim to achieve adequate completeness of data in the excluded centers and will implement regular audits. Second, the occurrence on skin graft failure after WE could not be evaluated due to the non-negligible number of unfilled forms. This limitation can be addressed by future improvements regarding information exchange among surgical centers involved in patient care.