Topical Tranexamic Acid Spray Versus No Spray on Postoperative Outcomes Following Mesh Repair of Umbilical Hernia

NCT07845370 | Not Yet Recruiting DMC

• 1 other identifier: Pakistan Railway Hospital
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical hernia is a type of ventral hernia that occurs commonly in adulthood, and mesh reinforcement is well established since there is a reduced recurrence rate when compared to suture repair. However, the repair of meshes could prove to be complex due to seroma, hematoma, wound infection, pain, and other surgical-site events.3 Seroma formation is considered clinically significant due to its ability to be painful, recurrent outpatient care, aspiration, infection, and slow wound healing.

Conditions

Umbilical Hernia Repair

Keywords

Umbilical Hernia; Tranexamic Acid; seroma

Outcome Measures

Primary Outcomes (2)

• Rate of Postoperative Seroma

  A post procedural presence of pale or clear, straw-colored swelling on the site of a surgery that occurred or happened within 30 days since the operation and has been identified clinically and had to be confirmed by the ultrasonographic method, in case of uncertainty

  30 days

• Rate of Postoperative Hematoma

  It is a localized pool of blood or clot at the operative site that occurs in the clinically and or ultrasonographically-it can be detected within 30 days after surgery.

  30 days

Study Arms (2)

Topical Tranexamic Acid Spray

EXPERIMENTAL

Drug: Topical Tranexamic Acid Spray

No Topical Tranexamic Acid Spray

PLACEBO COMPARATOR

Drug: No Topical Tranexamic acid

Interventions

No Topical Tranexamic acid DRUG

Every patient will receive standardized elective open mesh repair of umbilical hernia surgery with the same operative technique, mesh position, preoperative perioperative antibiotic prevention and postoperative analgesic regimen within the limits of possibilities. Wound closure in the control group will be done without the use of topical tranexamic acid. Operative time, predicted intraoperative bleeding, mesh properties, to place drain, and intrasurgery complications will be recorded

No Topical Tranexamic Acid Spray

Topical Tranexamic Acid Spray DRUG

In the intervention group, a mesh will be applied and adequate hemostasis established then 1 g tranexamic acid will be sprayed all over the operative field in total volume of 10 mL of normal saline just before wound closure. Wound closure in the control group will be done without the use of topical tranexamic acid. Operative time, predicted intraoperative bleeding, mesh properties, to place drain, and intrasurgery complications will be recorded

Topical Tranexamic Acid Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years.
• Either gender.
• Patient has primary umbilical hernia.
• To have elective umbilical hernia open meshes repair planned.
• Hernia defect that can be repaired with the help of the standardized mesh technique that was used in the study.
• ASA physical status I-III.
• No acute infection in or about the site of operations.
• Able to provide written informed consent

You may not qualify if:

• Emergency with incarcerated, obstructed, or strangulated umbilical hernia.
• Frequent umbilical or ventral hernia.
• Major abdominal surgery scheduled concomitants on the same surgery.
• Active local or systemic infection.
• Hypersensitivity known to tranexamic acid.
• History or current deep-vein thrombosis or pulmonary embolism or other thromboembolic hemorrhagic disease.
• Known inherited/acquired thrombophilia.
• Greater renal impairment that needed to be avoided or have its dosage increased significantly with tranexamic acid.
• History of seizures/ epilepsy where tranexamic acid is inappropriate.
• The presence of currently used therapeutic anticoagulation which may not be controlled accordingly during operation.
• Coagulopathy or known bleeding.
• Pregnancy or breastfeeding.
• Patients who need a significantly different operative or mesh method intraoperative

Sponsors & Collaborators

• Dr Mudassar Saeed Pansota: lead

Study Sites (1)

Pakistan Railway Hospital, Rawalpindi

Rawalpindi, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Hernia, Umbilical; Seroma

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Study Officials

• Saleh Tariq Kazi, MBBS

  Pkistan Railway Hospital, Rawalpindi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh Tariq Kazi, MBBS

CONTACT

03100089237; salehtk36@gmail.com

mudassar pansota, MS urology

CONTACT

netygeulis749@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

PA (1)