Randomized trial of drain antisepsis after mastectomy and immediate prosthetic breast reconstruction.

BACKGROUND: In this 2-site randomized trial, we investigated the effect of antiseptic drain care on bacterial colonization of surgical drains and infection after immediate prosthetic breast reconstruction. METHODS: With IRB approval, we randomized patients undergoing bilateral mastectomy and reconstruction to drain antisepsis (treatment) for one side, with standard drain care (control) for the other. Antisepsis care included both: chlorhexidine disc dressing at drain exit site(s) and irrigation of drain bulbs twice daily with dilute sodium hypochlorite solution. Cultures were obtained from bulb fluid at 1 week and at drain removal, and from the subcutaneous drain tubing at removal. Positive cultures were defined as ≥1+ growth for fluid and >50 CFU for tubing. RESULTS: Cultures of drain bulb fluid at 1 week (the primary endpoint) were positive in 9.9 % of treatment sides (10 of 101) versus 20.8 % (21 of 101) of control sides (p = 0.02). Drain tubing cultures were positive in 0 treated drains versus 6.2 % (6 of 97) of control drains (p = 0.03). Surgical site infection occurred within 30 days in 0 antisepsis sides versus 3.8 % (4 of 104) of control sides (p = 0.13), and within 1 year in three of 104 (2.9 %) of antisepsis sides versus 6 of 104 (5.8 %) of control sides (p = 0.45). Clinical infection occurred within 1 year in 9.7 % (6 of 62) of colonized sides (tubing or fluid) versus 1.5 % (2 of 136) of noncolonized sides (p = 0.03). CONCLUSIONS: Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains, and reduced drain colonization was associated with fewer infections.

Risk factors associated with breast lymphedema.

BACKGROUND: The development of breast lymphedema (BLE) after breast/axillary surgery is poorly characterized. We prospectively evaluated clinical and surgical factors associated with development of BLE. METHODS: Patients undergoing unilateral breast-conserving surgery were prospectively enrolled preoperatively and followed for development of BLE. To augment the number of patients with BLE for evaluation of risk factors, postoperative patients identified in the clinic with signs and symptoms of BLE were also enrolled. Logistic regression with Firth's penalized likelihood bias-reduction method was used for univariate and multivariate analysis. RESULTS: Of 144 women, 124 were enrolled preoperatively (38 of whom developed BLE), and 20 women with BLE were enrolled postoperatively. Any type of axillary surgery was the strongest factor associated with BLE (odds ratio, 134; 95 % confidence interval, 18 to >1,000). All 58 BLE events occurred in women with axillary surgery as compared with no events in the 46 patients without axillary surgery (p < 0.0001). Among 98 women who underwent axillary surgery, BLE did not occur more often after axillary lymph node dissection versus sentinel lymph node biopsy (p = 0.38) and was not associated with total number of nodes removed (p = 0.52). In multivariate analysis, factors associated with the development of BLE in the axillary surgery subgroup included baseline BMI (p = 0.004), incision location (p = 0.009), and prior surgical biopsy (p = 0.01). CONCLUSIONS: Risk of BLE is primarily related to performance of any axillary surgery but not the extent of axillary surgery or number of lymph nodes removed. Other factors associated with BLE were increased body mass index, incision location, and prior surgical excisional biopsy.

Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations.

OBJECTIVE: To determine whether bacterial colonization of drains can be reduced by local antiseptic interventions. BACKGROUND: Drains are a potential source of bacterial entry into surgical wounds and may contribute to surgical site infection after breast surgery. METHODS: After institutional review board approval, patients undergoing total mastectomy and/or axillary lymph node dissection were randomized to standard drain care (control) or drain antisepsis (treated). Standard drain care comprised twice daily cleansing with alcohol swabs. Antisepsis drain care included (1) a chlorhexidine disc at the drain exit site and (2) irrigation of the drain bulb twice daily with dilute sodium hypochlorite (Dakin's) solution. Culture results of drain fluid and tubing were compared between control and antisepsis groups. RESULTS: Overall, 100 patients with 125 drains completed the study with 48 patients (58 drains) in the control group and 52 patients (67 drains) in the antisepsis group. Cultures of drain bulb fluid at 1 week were positive (1+ or greater growth) in 66% (38/58) of control drains compared with 21% (14/67) of antisepsis drains (P = 0.0001). Drain tubing cultures demonstrated more than 50 colony-forming units in 19% (8/43) of control drains versus 0% (0/53) of treated drains (P = 0.004). Surgical site infection was diagnosed in 6 patients (6%)--5 patients in the control group and 1 patient in the antisepsis group (P = 0.06). CONCLUSIONS: Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains. Based on these data, further study of drain antisepsis and its potential impact on surgical site infection rate is warranted (ClinicalTrials.gov Identifier: NCT01286168).

A prospective study of breast lymphedema: frequency, symptoms, and quality of life.

Although lymphedema of the arm is a well-known complication of breast and axillary surgery, breast lymphedema has received scant attention. We sought to prospectively characterize breast lymphedema's incidence, associated symptoms, clinical course, and impact on quality of life. Subjects were enrolled prospectively from a consecutive sample of patients undergoing non-mastectomy breast procedures (excisional biopsy or wide local excision ± lymph node removal) and followed for signs and symptoms of lymphedema in the operated breast. Symptoms and distress were serially assessed with 11-point linear analog scales. Breast lymphedema was diagnosed independent of symptoms, based on the distribution and degree of edema and erythema. One hundred twenty-four women were followed for a median of 11 months, and breast lymphedema was diagnosed in 38 (31%) women. Breast lymphedema was more frequent after breast surgery with axillary node removal (49%) compared to breast surgery alone (0%), p < 0.0001. Breast lymphedema involved multiple quadrants in most women and was characterized by edema in 100% and erythema in 79%. Patients with breast lymphedema were significantly more likely than women without breast lymphedema to report symptoms of breast heaviness (65% vs 22%, p < 0.0001), redness (62% vs 29%, p = 0.0006), and swelling (59% vs 22%, p < 0.0001), but symptom-associated distress was low overall. Three of 32 breast lymphedema patients with clinical follow-up developed chronic edema. Breast lymphedema occurs in approximately one-half of women who undergo breast surgery with axillary node removal. The condition is characterized by diffuse skin edema and erythema as well as self-reported symptoms with a low level of distress.