Assessment of Long Term, Endovascular AAA Intervention using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis (NCT06218875)

This prospective, intra-subject controlled trial will evaluate the effect of Intense Pulsed Light (IPL) therapy on vascularity and scar outcomes in 20 adults with split-thickness skin graft donor sites at increased risk of hypertrophic scarring. Each participant will have two comparable donor-site areas, with one receiving IPL plus standard scar management and the other receiving standard scar management alone as an intra-subject control. IPL treatment will commence 12 weeks after complete epithelialisation, with three treatment sessions at eight-week intervals. Scar vascularity will be objectively assessed using Antera 3D imaging, with secondary outcomes including scar quality using POSAS 3.0 and health-related quality of life using the EQ-5D. Participants will be followed for 12 months following the final treatment.

Trial phase

Other

Trial participation type

This trial has been designed for Registry.

Principal investigator

Mr Thodur Vasudevan

Key inclusion data

SIGNIFICANT INCLUSION CRITERIA: 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements. 2. Patient has been or is intended to be treated with an eligible registry device. * 3. Patient is age ≥ 18 years at time of informed consent signature. SIGNIFICANT EXCLUSION CRITERIA: 1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site’s guidelines and procedures. 2. Patient with exclusion criteria required by local law. 3. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment*. Subjects cannot be enrolled in another Together Registry module protocol.