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

Post-mastectomty Seroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730674
• Other study ID #: predictors of tetracycline
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Post-mastectomty Seroma
• Seroma

Intervention

Drug:
• tetracycline 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Zagazig	Sharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of injection sessions to reach complete resolution of seroma	number of injection sessions to reach complete resolution of seroma	5 days