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

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04730674
Collaborator
(none)
18
1
1
5.9
3

Study Details

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
  • Drug: tetracycline mixed with xylocaine
N/A

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
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 :
Jan 1, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 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 [5 days]

    number of injection sessions to reach complete resolution of seroma

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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:
  • 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

Site City State Country Postal Code
1 Faculty of Medicine Zagazig Sharqia Egypt 44519

Sponsors and Collaborators

  • Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 29, 2021
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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:

Study Results

No Results Posted as of Jan 29, 2021