Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.
Primary Purpose
Post-mastectomty Seroma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tetracycline mixed with xylocaine
Sponsored by
About this trial
This is an interventional diagnostic trial for Post-mastectomty Seroma
Eligibility 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
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
post-mastectomty seroma group
Arm Description
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.
Outcomes
Primary Outcome Measures
The number of injection sessions to reach complete resolution of seroma
number of injection sessions to reach complete resolution of seroma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04730674
Brief Title
Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.
Official Title
Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-mastectomty Seroma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
post-mastectomty seroma group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tetracycline mixed with xylocaine
Intervention Description
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 Outcome Measure Information:
Title
The number of injection sessions to reach complete resolution of seroma
Description
number of injection sessions to reach complete resolution of seroma
Time Frame
5 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Faculty of Medicine
City
Zagazig
State/Province
Sharqia
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.
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