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CTRI Number  CTRI/2024/12/077847 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Topical Tranexamic Acid in reduction of seroma after Modified radical mastectomy. 
Scientific Title of Study   Effect of topical tranexamic acid in reducing axillary drain output post modified radical mastectomy Surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeep Kumar Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No 401 4th Floor Academic Block AIIMS Bhubaneswar Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  8789395345  
Fax    
Email  emailpradeep2310@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akarsh I A 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of General Surgery, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar.

Khordha
ORISSA
751019
India 
Phone  9543243166  
Fax    
Email  iaakarsh1998@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pradeep Kumar Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Room No 401 4th Floor Academic Block AIIMS Bhubaneswar Sijua Patrapada


ORISSA
751019
India 
Phone  8789395345  
Fax    
Email  emailpradeep2310@gmail.com  
 
Source of Monetary or Material Support  
Dr Pradeep Kumar Singh, Room No 401, Academic Block, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odosha, PIN-751019 
 
Primary Sponsor  
Name  Pradeep Kumar Singh 
Address  Room No 401 4th Floor Academic Block AIIMS Bhubaneswar Sijua Patrapada Bhubaneswar-751019 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep Kumar Singh  All India Institute of Medical Sciences Bhubaneswar  Department of General Surgery All India Institute of Medical Sciences Bhubaneswar Sijua Patrapada Bhubaneswar
Khordha
ORISSA 		 8789395345

emailpradeep2310@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Local application of Normal saline  Single time local application of 20 ml of Normal saline in axillary bed before skin closure following modified radical mastectomy. 
Intervention  Local application of Tranexamic acid  Single time application of Local Tranexamic acid in axillary bed after skin closure after modified radical mastectomy in a strength of 500 mg diluted with normal saline to make a volume of 20ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  All patients above 18 years of age diagnosed with breast carcinoma undergoing modified radical mastectomy 
 
ExclusionCriteria 
Details  Pregnancy
Patients with known thromboembolic disease
Patients not giving consent or not understanding the nature of the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to study the effects of topical tranexamic acid application on
axillary drain output post modified radical mastectomy 		 Daily drain output will be measured. The drain will be removed on the day when the daily drain output recorded will be less than 30ml on two consecutive days. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of seroma formation after drain removal at the end of three months
Incidence of surgical site infection at day 30 after MRM
Day of conversion of nature of drain fluid from sanguineous to serous. 		 Incidence of surgical site infection at the end of 30 days.
Incidence of seroma formation at the end of three months.
Day of Day of conversion of nature of drain fluid from sanguineous to serous. 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [emailpradeep2310@gmail.com].

  6. For how long will this data be available start date provided 31-07-2025 and end date provided 31-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Breast cancer is one of the most common cancer being diagnosed in women which accounts for more than 1 in 10 new cancer diagnosed every year. It is the second most common cause of death from cancer among women in the world. The most common procedure used at present is the modified radical mastectomy. One of the major complications associated with Modified radical mastectomy is seroma formation with the incidence rate reaching up to 18% which leads to delayed drain removal and increased hospital stay. Duration of surgery is directly associated with an increased risk of seroma formation. Factors like the level of lymph nodes and tumor size have been inconclusive in establishing an association with seroma formation. This study aims to study the role of tranexamic acid on this very common but important side effect of a very commonly performed surgery. Tranexamic acid is a synthetic derivative of lysine that blocks lysine binding sites on plasminogen which inhibits plasminogen thereby leading to reduced formation of plasmin. This leads to an overall reduction in fibrinolysis and reduction in blood loss. Seroma formation is related to local fibrinolytic activity, Being an anti-fibrinolytic, the local application of tranexamic acid looks promising in reducing seroma formation. Some studies have shown local application of tranexamic acid has equal efficacy as compared to IV administration for reduction in blood loss and better bone healing and granulation. The safety profile of Tranexamic acid remains in question due to a potential increased risk of venous thromboembolism. By applying TXA topically as opposed to intravenously, systemic absorption may be reduced and unwanted side effects mitigated. Tranexamic acid has immunomodulatory action independent of its action on plasminogen. This action of tranexamic acid can be correlated with surgical site infection rates. Tranexamic acid directly reduces fibrinolytic activity and hence modified radical mastectomy is a good choice of surgery to study the topical effect of Tranexamic acid.


 
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