Buda, A., Ghelardi, A., Fruscio, R., Guelfi, F., La Manna, M., Dell'Orto, F., & Milani, R. (2016). The contribution of a collagen-fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: A double institution observational study. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 197, 156–158. 

DOI Link

Study Purpose

To describe the effects of using a collagen fibrin patch on complications after inguinofemoral lymphadenectomy for gynecologic cancer

Intervention Characteristics/Basic Study Process

Outcomes in consecutive women who underwent groin dissection using the fibrin patch were compared to historical controls who did not use the patch. The same surgical teams performed the procedures. The patch used contained a collagen matrix coated with coagulation factors that cause adhesion between the patch and wound surfaces. Short-term postoperative results and long-term complications, such as cellulitis and late lymphedema, were compared between groups.

Sample Characteristics

  • N = 49   
  • MEAN AGE = 74.3 years
  • AGE RANGE = 48–95 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Most had vulvar primary tumors.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Italy

Study Design

Observational with historical control comparison

Measurement Instruments/Methods

Method of lymphedema determination or measurement is not described.

Results

In the control group, 24% developed late lymphedema, compared to 4% of patients in the group that did not use the patch. No significant differences were observed between groups in the proportion of those who had mono- or bilateral dissections or the number of lymph nodes removed, although the fibrin patch group had a slightly lower number of lymph nodes removed and fewer underwent adjuvant radiotherapy.

Conclusions

The findings suggest that the use of the fibrin patch may be helpful to prevent some complications of lymphadenectomy; however, stronger research evidence is needed for evaluation.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

Nursing Implications

Various surgical techniques are being examined for their effects on lymphedema-related outcomes after lymph node resections. Ongoing research is needed to determine the overall effectiveness of various techniques. Limited evidence exists for interventions to prevent and manage lower limb lymphedema.