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

Quality of Life Clinical Trial

Official title:

Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188821
• Other study ID #: 01/2019
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Quality of Life
• Safety Issues

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