Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508879
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial Does the Use of Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OHSCWD
Brief Summary:
Wound healing disorders are a major problem in cardiac surgery They prolong the inpatient stay and are associated with a high health and above all psychological burden for patients They also represent a major organizational medical and financial challenge for the treatment team There is therefore still a great need for effective prevention of wound healing disorders It goes without saying that wound management plays a major role in the development of wound healing disorders Nowadays there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis One point of criticism is that most of the existing studies are financed by the manufacturer Due to the otherwise broad range of applications for all wounds in various specialist areas it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders especially in cardiac surgery After extensive literature research we are of the opinion that the Aquacel Surgical Ag dressing a new silver-coated hydrocolloid dressing can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disordersThe study is a randomized prospective clinical trial It is being conducted at the Clinic for Cardiothoracic and Vascular Surgery and has already been approved by the Rhineland-Palatinate Ethics Committee The study should include 440 heart patients and last for 12 months It will compare the Aquacel Surgical Ag bandage against our conventional methods This study is being conducted independently of the industry We want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic If the outcome of the study is positive this dressing will be be used regularly in our cardiac surgery clinic
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None