Carlson, J.W., Kauderer, J., Walker, J.L., Gold, M.A., O'Malley, D., Tuller, E., . . . Gynecologic Oncology Group. (2008). A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: A Gynecologic Oncology Group Study. Gynecologic Oncology, 110(1), 76–82.

To test the hypothesis that patients who receive a vapor-heated (VH) fibrin sealant in the inguinal wound following inguinal lymphadenectomy in conjunction with treatment of a vulvar neoplasm would experience a 25% reduction in the incidence of grade 2 and 3 lymphedema of the lower extremity compared to control patients

Patients were randomized to the investigational or control arm of the study. In the investigational arm (FS), VH fibrin sealant was applied to the inguinal wound base. In the control arm (SC), the closure of the wound was performed without application of the fibrin sealant. Patients were assessed prior to treatment and postoperatively at the time of drain removal, at six weeks, and at three and six months.

• The study sample (N = 137) was comprised of female patients with a vulvar malignancy.
• Patients were randomized to the FS arm (n = 70) or the SC arm (n = 67).
• Median age in the FS arm was 61 years, with a range of 30–90 years; median age in the SC arm was 57 years, with a range of 33–87 years.
• All patients were undergoing a radical vulvectomy or hemivulvectomy with either an ipsilateral or bilateral inguinal lymphadenectomy.

The study was conducted at multiple Gynecologic Oncology Group member institutions across the United States.

The study used a randomized phase III trial design.

• Circumference was measured to determine leg lymphedema.
• Surgical complications were measured, including vulvar wound separation, inguinal wound separation, grading of infection or cellulitis, and grading of seroma or lymphocyst.
• Duration of drain and drain output in the 24 hours prior to drain discontinuation also were evaluated.

The incidence of grade 2 and 3 lymphedema was 67% in the SC arm and 60% in the FS arm (p = 0.4779). The incidence of lymphedema was strongly associated with inguinal infection (p = 0.0165). No statistically significant difference was found in duration of drains or drain output or incidence of inguinal infections, wound breakdowns, or seromas. The FS arm experienced an increased incidence of vulvar infections (p = 0.0098).

VH fibrin sealant in inguinal lymphadenectomies does not reduce leg lymphedema and may increase the risk for complications in the vulvar wound.

• The sample size in each group was small, with less than 100 participants.
• Follow-up for circumferential measurement occurred only through six months.
• The protocol prescribed 10–15 lb of pressure over the wound bed after the VH fibrin sealant had been applied, but the exact location and amount of pressure over the wound was not monitored.

Future trials should be designed to evaluate surgical techniques and postoperative care that would decrease wound breakdowns and complications while monitoring for variables that may be related to increased incidence of swelling or lymphedema in patients with vulvar cancer.