Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander

Not Applicable

Completed

• Conditions: Quality of Life; Safety Issues
• Interventions: Procedure: breast drain removal

• Registration Number: NCT04188821
• Lead Sponsor: University of Foggia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-12-31
• Study First Submitted: 2019-11-28
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-06
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
output based group	breast drain removal	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
early-removal group	breast drain removal	Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time

Primary Outcome Measures

Name	Time	Method
total fluid volume (ml)	21 days	sum of drain volumes and volume of seroma aspirations if needed
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
complicated wound healing (yes or not)	21 days	unclosed wound 3 weeks postoperatively
days of seroma formation	21 days	period that drain or seroma aspiration is needed in days after surgery
days with drainage	21 days

Secondary Outcome Measures

Name	Time	Method
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)
disturbance in quality of sleep (yes or not)	21 days
disturbance in mobility (yes or not)	21 days	mobility as walking, running, driving
limitation in personal care, daily activities and social life (yes or not)	21 days