RecruitingACTRN12616001206415

Does the Alexis retractor increase the risk of blood splashes to surgeons' face.

Does the Alexis retractor increase the risk of blood splashes to surgeons' face during laparotomy surgeries.

Sponsor

Geelong Hospital (Barwon Health)

Enrollment

100 participants

Start Date

Jul 13, 2016

Study Type

Interventional

Conditions

Laparotomy

Summary

Does the Alexis Wound Retractor increase the risk of conjunctival contamination from blood splashes during surgery? Background: Blood splashes to the face/ eyes are a recognised risk to the surgeon and assistants Alexis retractor is commonly used during laparotomy, laparoscopic operations and caesareans Increase exposure, protect wound, reduce wound infection Concern: blood droplets spraying into the air/ face/ eyes during removal Aim: Assess whether there is an increased risk of blood splashes during operations when the Alexis retractor is used Design: Double blinded randomised trial including all abdominal operations in which Alexis retractor may be used Surgeons and assistants will wear visors Randomised to Alexis or no Alexis End point: number of blood splashes on visors Power calculations 44 in each group Aim to recruit 50 in each group

Eligibility

Sex: Both males and femalesMin Age: 10 Yearss

Plain Language Summary

Simplified for easier understanding

This surgical study is investigating whether a common wound-protecting device called the Alexis retractor increases the chance of blood splashing onto the faces or eyes of surgeons during abdominal surgery. Surgeons will wear protective visors and be randomly assigned to use the device or not, and researchers will count how many blood splashes occur. You may be eligible if: - You are scheduled to have an abdominal (laparotomy) surgery - You are 10 years of age or older You may NOT be eligible if: - Using or not using the Alexis retractor would compromise your surgical safety (as determined by your surgeon) Talk to your doctor about whether this trial might be right for you.

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Interventions

This is a randomised controlled single centre trial where surgeons will be asked to wear a clear plastic visor, in addition to protective clothing normally used during surgery. Surgeons performing open abdominal surgery at University Hospital Geelong will be asked to participate. Participation in this research will not affect the choice of procedure or care provided to patients. No samples will be collected at any time during this study. Surgeons will be randomly allocated either to use Alexis retractor or not to use it during their operations. Blood spatter caught on the surgeon’s visor will be quantified after surgical procedures involving the abdomen. Clear plastic visors will be examined on a black background. Macroscopic blood spatter will be graded by size and count, and whether the blood is dripping or not. Microscopic blood spatter will be counted. Counted blood droplets will be marked with a black marker to prevent double-counting. Results will then be compared for surgeries in which the Alexis Wound Retractor was used compared to those during which this instrument was not used. Surgeons participating in the study will be allowed to insert and remove the Alexis retractor in their usual method with no restriction to the style of insertion or time taken to remove it.