Quality of Life, Safety Issues
Conditions
Brief summary
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle drain itself may perpetuate the drainage with vacuum mechanism); 2) reduce the risks connected to foreign body reaction as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.
Interventions
PROCEDUREbreast drain removal
Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing (complicated, see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care.
Sponsors
University of Foggia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and immediate positioning of breast expander (without mesh) with placement of suction drain, regardless of TNM classification
Exclusion criteria
* skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complicated wound healing (yes or not) | 21 days | unclosed wound 3 weeks postoperatively |
| days with drainage | 21 days | — |
| days of seroma formation | 21 days | period that drain or seroma aspiration is needed in days after surgery |
| time until wound healing (days) | 21 days | — |
| infection (yes or not) | 21 days | defined as the appearance of local signs/symptoms as erythema, edema, induration, increased pain, and a change in drainage to a purulent nature and fever, confirmed by swabs |
| total fluid volume (ml) | 21 days | sum of drain volumes and volume of seroma aspirations if needed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disturbance in quality of sleep (yes or not) | 21 days | — |
| limitation in personal care, daily activities and social life (yes or not) | 21 days | — |
| disturbance in mobility (yes or not) | 21 days | mobility as walking, running, driving |
| pain (using Visual Analogic Score scale to measure intensity) | 21 days | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain (0) and worst pain. (10) |
Outcome results
None listed