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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr Mudassar Saeed Pansota

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: Topical Tranexamic Acid SprayExperimental treatment 1 intervention
Group B: No Topical Tranexamic Acid SprayPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days
2

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.

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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Dr Mudassar Saeed Pansota

Lead sponsor

Shahida Islam Medical Complex

Sponsor institution

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