Could a Warm-Up device save breast reconstruction skin?

NCT ID NCT07340632

Not yet recruiting Symptom relief Sponsor: Plexaa Ltd Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a device called BLOOM43 that warms the breast skin the night before reconstructive surgery after mastectomy. The goal is to see if preconditioning reduces skin necrosis (tissue death) and improves healing. Sixty women undergoing immediate breast reconstruction will use the device at home and report their experience.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: BLOOM43 preconditioning device (heat therapy)
What this could lead to: If it works, this could reduce skin necrosis and improve recovery after breast reconstruction surgery.
What could go wrong: This is a small pilot study (60 participants) with no control group, so results may not be conclusive. The device is new and its benefits are unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer Necrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST RECONSTRUCTION BREAST SURGERY SKIN NECROSIS

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••
Contact

Phone: •••-•••-•••• Email: •••••@•••••

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