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

• ClinicalTrials.gov Identifier: NCT04730674
• Recruitment Status: Completed
• First Posted: January 29, 2021
• Last Update Posted: January 29, 2021
• Sponsor: Zagazig University
• Information provided by (Responsible Party): Joseph Rizk Awad, Zagazig University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-mastectomty Seroma	Drug: tetracycline mixed with xylocaine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2020

Arms and Interventions

Arm

Intervention/treatment

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; 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Faculty of Medicine

Zagazig, Sharqia, Egypt, 44519

Sponsors and Collaborators

Zagazig University

More Information

• Responsible Party: Joseph Rizk Awad, lecturer of surgery, faculty of human medicine, Zagazig University
• ClinicalTrials.gov Identifier: NCT04730674
• Other Study ID Numbers: predictors of tetracycline
• First Posted: January 29, 2021
• Last Update Posted: January 29, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Seroma; Inflammation; Pathologic Processes; Tetracycline; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors