An interventional study of tetracycline mixed with xylocaine in Post-mastectomty Seroma, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by Zagazig University · Not applicable, Interventional, and Diagnostic
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.
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:
The amount of seroma aspirated in each session in addition to the complications if present were recorded.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
The number of injection sessions to reach complete resolution of seroma
number of injection sessions to reach complete resolution of seroma
Time frame: 5 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jun 2020, 5 months.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 5 months is below that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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