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Investigating the Use of Drains and (Internal) Quilting Sutures on Seroma Formation Following Mastectomy

NCT02668263 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-01-29

No results posted yet for this study

Summary

Seroma formation is a common complication following breast and axillary surgery for breast cancer. The use of drains is commonplace in practice after mastectomy, although there is evidence to suggest that they do not affect the incidence of symptomatic seroma formation. Methods have been adopted in attempts to decrease seroma formation, to varying results, which include the use of deep sutures. The aim of this study is to evaluate the effect of drains and quilting sutures on the incidence of seroma formation. Patients undergoing mastectomy and axillary surgery for breast cancer will be eligible. Patients will be randomized to either receive a drain, no drain or no drain with quilting sutures. The primary outcome measure will be the incidence of symptomatic seroma. Secondary outcome measures will be postoperative length of stay and postoperative pain scores.

Conditions

Interventions

PROCEDURE

Surgery alone

Surgery

PROCEDURE

Surgery and Drain(s)

Drains inserted as per standard practice

PROCEDURE

Surgery and Quilting Sutures

Quilting sutures to mastectomy flaps

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER

  • Gateshead Health NHS Foundation Trust

    collaborator OTHER

  • Northumbria Healthcare NHS Foundation Trust

    collaborator OTHER

  • North Tees and Hartlepool NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Pud Bhaskar, MBBS, MD · North Tees & Hartepool NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02668263 on ClinicalTrials.gov