NCT03135080

The Effect of Long-Term HEAD START Training on Surgical Skill Levels

Completed NA Last updated 15 March 2018

What this trial tests

NA trial testing Long-Term HEAD START Training in Trichiasis in 30 participants. Completed in 26 February 2018.

Timeline

17 May 2017

Primary endpoint
26 February 2018

26 February 2018

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	30
Start date	17 May 2017
Primary completion	26 February 2018
Estimated completion	26 February 2018
Sites	3 locations across Ethiopia

Drugs / interventions tested

• Long-Term HEAD START Training
• Standard of Care

Conditions studied

• Trichiasis — all drugs for Trichiasis →
• Surgery — all drugs for Surgery →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 20 to 70, any sex, with Trichiasis or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The research group developed a surgical simulation device, the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery. In most settings, HEAD START is utilized once during training, then surgeons move on to live surgery and typically do not return to the simulator. The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training, since many surgeons operate seasonally, with long periods of downtime between surgical camps and with little field supervision.

Participating surgeons will practice on HEAD START weekly, with monthly feedback from a senior supervisor. Researchers will assess their skill level at the start of HEAD START training and again at the start of the new surgical season in the fall of 2017. Researchers will also administer questionnaires to elicit feedback on the HEAD START training and supervision process.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trachomatous trichiasis surgeons appreciate using HEAD START for extended training during periods of low surgical activity: A preliminary study.
   Tulenko SE, Bayissasse B, Admassu F, Alemayehu W, et al · · 2026 · PMID 41746967 · DOI 10.1371/journal.pntd.0013948