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OpenTrials
Completed

NCT Number: NCT04730674

Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.

female patients with established diagnosis of post-mastectomy seroma following modified radical mastectomy, were treated by local injection of tetracycline after the seroma fluid was aspirated, then a crepe bandage was applied over the mastectomy area. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications. The amount of seroma aspirated in each session.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

About this study

In this study, 18 patients with established diagnosis of post-mastectomy seroma were included. All of them were females undergoing modified radical mastectomy where seroma appeared after drain removal.

The age, co-morbidities, total leukocytic count (as an indicator of infection), serum albumin and tumour size and pathology for all of them were recorded. Then we interfered with our tetracycline injection technique for the treatment of seroma.

All the patients were consented regarding this therapeutic technique explaining the expected possible occurrence of some pain during and after injection, other complications like wound infection or flap necrosis necessitating further intervention. Moreover, repetition of the technique may be needed

In our technique the following was adopted:

  • First, the seroma fluid was aspirated completely using a 20 cc syringe while the patient lying flat and the needle inserted in the most dependent area
  • Then, 10 cc of saline containing 2 gm of tetracycline mixed with 5 ml of 2% xylocaine (as a pain relieving agent) was injected at the seroma bed.
  • After completion of injection, a crepe bandage was applied over the mastectomy area (flaps covering the seroma bed)
  • Then after 5 days the patient were examined again for seroma re-collection or the presence of complications as infection or flap necrosis. If there were any re-collection, the tetracycline injection procedure would be repeated.

The amount of seroma aspirated in each session in addition to the complications if present were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any patient with post-mastectomy seroma following modified radical mastectomy after removal of drain
  • no signs of infection or flap necrosis

Exclusion criteria

  • patients with post-mastectomy seroma following modified radical mastectomy with drain still in
  • if signs of infection or flap necrosis present

Treatment and study plan

tetracycline mixed with xylocaine

Drug

10 cc of saline containing 2 gm of tetracycline mixed with 5 ml of 2% xylocaine (as a pain relieving agent) was injected at the seroma bed.

Primary outcomes

  1. The number of injection sessions to reach complete resolution of seroma

    Time frame: 5 days

    number of injection sessions to reach complete resolution of seroma

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2021
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.