Mastectomy - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

North Tees and Hartlepool NHS Foundation Trust

Recruitment countries:

United Kingdom

Health condition studied:

Breast Cancer

URL:

Link to the clinical trial website

About the trial

Interventions:

Procedure: Surgery alone
Procedure: Surgery and Drain(s)
Procedure: Surgery and Quilting Sutures

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Females presenting with newly diagnosed carcinoma of the breast with or without
  axillary node clearance or sampling.
  
  - They must be at least 18 years of age and have capacity to give informed consent.
  
  Exclusion Criteria:
  
  - Male
  
  - Those who do not have capacity
  
  - Previous breast cancer in the same breast and previous axillary surgery
  
  - Previous chest wall radiotherapy
  
  - Patients with metastatic cancer including lymphoma, pre-existing lymphoedema
  
  - Intercurrent infection or hypoalbuminaemia (<36 g/L)
  
  - Patients part of other research trials.
  

• Age minimum:  18 Years
• Age maximum:  N/A
• Gender:  Female

Primary outcomes:

Seroma formation

Secondary outcomes:

Length of Stay
Pain scores
Seroma aspiration

Target sample size:

120

Study type:

Interventional

Study design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name:   Pud Bhaskar, MBBS, MD
• Address: 
• Phone: 
• Email: 
• Affiliation:  North Tees & Hartepool NHS Foundation Trust

• Name:   Pud Bhaskar, MBBS, MD
• Address: 
• Phone:  01642 624710
• Email:  pud.bhaskar@nth.nhs.uk
• Affiliation: 

Technical details

Scientific title:

Randomised Clinical Trial Investigating the Use of Drains and Quilting Sutures on Seroma Formation Following Mastectomy - A Pilot Study

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Gateshead Health NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Northumbria Healthcare NHS Foundation Trust

Main ID:

NCT02668263

Secondary ID:

NorthTeesNHS
RECRef:14/NE/0091 R&D SUR094

Register:

ClinicalTrials.gov

Date of registration:

18/01/2016

Date of first enrollment:

November 2015

Last refreshed:

8 February 2016