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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04188821
Other study ID # 01/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date December 31, 2018

Study information

Verified date December 2019
Source University of Foggia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date December 31, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Foggia

Outcome

Type Measure Description Time frame Safety issue
Primary total fluid volume (ml) sum of drain volumes and volume of seroma aspirations if needed 21 days
Primary days with drainage 21 days
Primary days of seroma formation period that drain or seroma aspiration is needed in days after surgery 21 days
Primary time until wound healing (days) 21 days
Primary 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 21 days
Primary complicated wound healing (yes or not) unclosed wound 3 weeks postoperatively 21 days
Secondary 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) 21 days
Secondary disturbance in quality of sleep (yes or not) 21 days
Secondary limitation in personal care, daily activities and social life (yes or not) 21 days
Secondary disturbance in mobility (yes or not) mobility as walking, running, driving 21 days
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