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Not yet recruiting NCT07340632

B4P Trial - BLOOM43 for Preconditioning

No phase Interventional Skin Necrosis Breast Reconstruction Breast Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BLOOM43.
Who it may be relevant to
Registry conditions: Skin Necrosis, Breast Reconstruction, Breast Surgery. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study

Overview

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. This study aims to understand a participant's experience of the device, including its usability and acceptability. Participants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).

Interventions

  • Device BLOOM43
    BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.

Primary outcome measures

  • Safety of the device [Time frame: 90 days]
  • Participant experience [Time frame: 30 days]
Secondary outcome measures (2)
  • Mastectomy skin flap necrosis [Time frame: 90 days]
  • Compliance [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

  • All females over the age of 18 years (no maximum age limit)
  • Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and/or implant)

Exclusion criteria

  • Delayed (two-stage) breast reconstruction patients
  • Patients undergoing simple mastectomy or wide local excision of a breast tumour
  • Inflammatory breast cancer patients
  • Patients with ulcerated breast tumours
  • Patents with T4 breast cancer
  • Presence of open breast skin wounds, or infected or inflamed breast skin
  • Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Jeevan R, Cromwell DA, Browne JP, Caddy CM, Pereira J, Sheppard C, Greenaway K, van der Meulen JH. Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1333-44. doi: 10.1016/j.bjps.2014.04.022. Epub 2014 May 14. PMID 24908545
  • Robertson SA, Jeevaratnam JA, Agrawal A, Cutress RI. Mastectomy skin flap necrosis: challenges and solutions. Breast Cancer (Dove Med Press). 2017 Mar 13;9:141-152. doi: 10.2147/BCTT.S81712. eCollection 2017. PMID 28331365
  • Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4. PMID 24011908
  • Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21. PMID 32505626
  • Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019. PMID 30656059

Identifiers

NCT: NCT07340632 · B4PTrial · NIHR206435

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗