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

NCT04188821 | Completed

• 1 other identifier: 01/2019
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Safety Issues; Quality of Life

Outcome Measures

Primary Outcomes (6)

• total fluid volume (ml)

  sum of drain volumes and volume of seroma aspirations if needed

  21 days

• days with drainage

  21 days

• days of seroma formation

  period that drain or seroma aspiration is needed in days after surgery

  21 days

• time until wound healing (days)

  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

  21 days

• complicated wound healing (yes or not)

  unclosed wound 3 weeks postoperatively

  21 days

Secondary Outcomes (4)

• pain (using Visual Analogic Score scale to measure intensity)

  21 days

• 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

Study Arms (2)

output based group

ACTIVE COMPARATOR

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

early-removal group

EXPERIMENTAL

Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time

Procedure: breast drain removal

Interventions

breast drain removal PROCEDURE

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.

early-removal group; output based group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection

Sponsors & Collaborators

• University of Foggia: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 6, 2019
• Study Start: September 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 10, 2019

Record last verified: 2019-12