The Effect of Octreotide on Wound Drainage After Mastectomy

What Was Tested

This registered phase 4 trial tested Octreotide.

Patients who had mastectomy for breast cancer usually have drainage of some fluid from the site of surgery.

This could be prolonged and may lead to other negative consequences after surgery.

It had two arms (groups): Octreotide group (active comparator) and Control group (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Study design and location: This was a randomised controlled trial carried out at the University College Hospital Ibadan, a premier teaching hospital in South West Nigeria.

Study population: Study participants were recruited from female breast cancer patients who presented through the Surgery Out-Patient (SOP) clinic of the University College Hospital, Ibadan to these general surgical divisions over the study period.

Sampling and randomisation technique: Convenience sampling of breast cancer patients presenting during the study period was employed.

Study participants were randomized into 2 groups, a treatment and a control group, using blocked sequence randomization.

Who Took Part

41 actual participants took part.

It was open to women only.

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

Examples of who could join: All female breast cancer patients requiring modified radical mastectomy.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: all mastectomies without axillary clearance (simple and toilet mastectomies); breast-conserving surgeries; patients undergoing immediate breast reconstruction after mastectomy.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2020-12-18 with completion listed for 2021-11-15.

It ran at 1 site in Nigeria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to drain removal.

It also tracked 1 secondary outcome, for example Incidence of seroma.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 41 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.