An interventional study of breast drain removal in Safety Issues and Quality of Life, sponsored by University of Foggia. Completed. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by University of Foggia · Not applicable, Interventional, and Treatment
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.
University of Foggia is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days with no further signs of infection, fluid collection or impaired wound healing
Procedure: breast drain removal
Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time
Procedure: breast 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.
total fluid volume (ml)
sum of drain volumes and volume of seroma aspirations if needed
Time frame: 21 days
days with drainage
Time frame: 21 days
days of seroma formation
period that drain or seroma aspiration is needed in days after surgery
Time frame: 21 days
time until wound healing (days)
Time frame: 21 days
infection (yes or not)
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
Time frame: 21 days
complicated wound healing (yes or not)
unclosed wound 3 weeks postoperatively
Time frame: 21 days
pain (using Visual Analogic Score scale to measure intensity)
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)
Time frame: 21 days
disturbance in quality of sleep (yes or not)
Time frame: 21 days
limitation in personal care, daily activities and social life (yes or not)
Time frame: 21 days
disturbance in mobility (yes or not)
mobility as walking, running, driving
Time frame: 21 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University of Foggia