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CompletedNCT04730674Updated Jan 29, 2021

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

An interventional study of tetracycline mixed with xylocaine in Post-mastectomty Seroma, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Zagazig University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Sex
Female
01

Study summary

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.

Read the detailed description

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:

  1. 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
  2. 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.
  3. After completion of injection, a crepe bandage was applied over the mastectomy area (flaps covering the seroma bed)
  4. 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.

02

Conditions studied

  • Post-mastectomty Seroma

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients with post-mastectomy seroma following modified radical mastectomy with drain still in
  • if signs of infection or flap necrosis present
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    post-mastectomty seroma group

    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.

    Drug: tetracycline mixed with xylocaine

Interventions

  • Drugtetracycline mixed with xylocaine

    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.

05

What researchers measure

Primary outcomes

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

    number of injection sessions to reach complete resolution of seroma

    Time frame: 5 days

06

Study locations

1 site
  • Faculty of Medicine
    Zagazig, Sharqia 44519, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04730674
Lead sponsor
Zagazig University
Responsible party
Joseph Rizk Awad (lecturer of surgery, faculty of human medicine, Zagazig University) — Principal investigator
First posted
Jan 29, 2021
Start date
Jan 1, 2020
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Jan 29, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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