Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07379294
Brief Summary:
The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.
Detailed Description:
The goal of this clinical trial is to learn if applying soft foam dressings (AQUACEL Foam Hydrofiber Dressing) can prevent surgery-related pressure injuries in adult patients (≥18 years) undergoing cardiac surgery under general anesthesia with cardiopulmonary bypass (CPB). The main questions it aims to answer are:
Does the use of soft foam dressings reduce the incidence of perioperative pressure injuries compared with routine skin protection measures alone? Does the intervention delay the time to pressure injury development and improve postoperative skin integrity during the first 5 postoperative days? Researchers will compare the intervention group (routine prevention + AQUACEL Foam applied to high-risk pressure areas) to the control group (routine prevention only) to see if the foam dressing intervention reduces pressure injury occurrence after cardiac surgery.
Participants will:
Be screened for eligibility and provide written informed consent Receive either routine pressure injury prevention care alone (control group) or routine care plus AQUACEL Foam dressings (intervention group) applied to pressure-prone areas (e.g., heels, sacrococcygeal region, and hallux bony prominence) Complete a demographic questionnaire (approximately 10 minutes; self-completed or assisted by the researcher)
Undergo skin assessments 6 times:
T0: during preoperative preparation T1: immediately after surgery T2-T5: once daily for 4 consecutive days after ICU transfer Have perioperative and clinical data collected from medical records (e.g., surgical duration, CPB time/temperature, laboratory values such as albumin, Hb, RBC, Hct, BUN, creatinine)
Study:
NCT07379294
Study Brief:
Protocol Section:
NCT07379294