About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-65 years.
Either gender.
Patient has primary umbilical hernia.
To have elective umbilical hernia open meshes repair planned.
Disqualifiers
• 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.
Trial design
Parallel
Treatments tested in this trial
Topical Tranexamic Acid Spray
DrugIn 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
No Topical Tranexamic acid
DrugEvery 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
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Sponsors and contacts
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Dr Mudassar Saeed Pansota
Lead sponsor
Shahida Islam Medical Complex
Sponsor institution
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