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

Not Applicable

Completed

• Conditions: Post-mastectomty Seroma
• Interventions: Drug: tetracycline mixed with xylocaine

• Registration Number: NCT04730674
• Lead Sponsor: Zagazig University

Brief 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.

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-01-29
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
post-mastectomty seroma group	tetracycline mixed with xylocaine	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.

Primary Outcome Measures

Name	Time	Method
The number of injection sessions to reach complete resolution of seroma	5 days	number of injection sessions to reach complete resolution of seroma

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Zagazig, Sharqia, Egypt