Role of Methylene Blue in Parotid Surgery

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

Usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery.

It had two arms (groups): MB group (active comparator) and Control group (no intervention).

Mb group will undergo surgeries with methylene blue staining.

Control group will undergo surgeries without methylene blue staining.

The registry classes the interventions as procedure.

More on the Plan

In addition to temporary facial weakness and permanent facial nerve injury, postparotidectomy depression and Frey's syndrome (gustatory sweating) are specific for this type of surgery.

To overcome this difficulty, an identification method might be used such as preoperative intravital staining of the gland with methylene blue (MB).

Although MB staining is not designed to be used as a sole technique, it can be combined with other techniques such as identification of the anatomic landmarks.

Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: All new cases presented with primary benign or malignant parotid tumors.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: cases with secondary tumors of the gland.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2022-06 with completion listed for 2023-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye (time frame: One year).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.