Clinical Research Directory

Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds

Sponsor: Dávid Ágoston Kovács

Summary

WALLAS is a small observational study of 30 adults with complex wounds in the abdominal wall after surgery. All participants will receive negative pressure wound therapy (NPWT) because their treating team considers it appropriate. This treatment uses a sealed dressing connected to a suction device. The study will not decide which treatment participants receive or change their usual care. The main aim is to find out how the stiffness of the large arteries changes during treatment. Researchers will also examine whether larger reductions in wound size and inflammation are linked to larger reductions in artery stiffness. An upper-arm cuff device will estimate artery stiffness by measuring how quickly pressure waves travel along the aorta, the body's main artery. Measurements are planned before treatment starts, around day 5, and when the first course of NPWT ends. Blood pressure will be taken into account when interpreting the results. During planned dressing changes, researchers will record wound depth and, when safe and technically possible, measure the wound cavity using sterile saline. Photographs will document the wound. Results from routine blood tests will provide information about inflammation; no extra blood samples are required for research. Wound recovery and further treatment will be followed for about six months after NPWT starts. The study will also assess how practical and safe the measurement procedures are. Because there is no comparison group, it cannot determine whether NPWT itself causes any changes in artery stiffness.

Official title: Longitudinal Changes in Arterial Stiffness During Negative Pressure Wound Therapy for Major Postoperative Abdominal Wall Wound Complications: A Prospective Observational Pilot Study Protocol

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