Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445699
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-21
Brief Title:
Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds
Sponsor:
Army Medical University China
Organization:
Army Medical University China
Study Overview
Official Title:
Investigation the Clinical Effectiveness of Combination Topical Aminolaevulinic Acid-Photodynamic Therapy With Hydrogel Dressing for Treatment Chronic Cutaneous Wounds
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
63 patients with chronic infectious wounds were enrolled in the controlled study They were randomly divided into three groups equally Group 1 Grp1 The patients received hydrogel dressing change at three days intervals Group 2 Grp2 The patients received ALA-PDT treatment at ten days intervals for 4 sessions Groups 3 Grp3 The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals The wound healing rate total effective rate patient satisfaction adverse reaction and recurrence were assessed in all groups
Detailed Description:
Randomly divide the enrolled patients into three groups for treatment by utilizing SAS software SAS Institute Cary NC USA Initially the wound pus and secretions were washed three times with a sterile saline solution Subsequently surgical instruments were employed to debride the wound particularly the necrotic tissue as well as any carrion and foreign bodies within the wound bed and cavity with care being taken to avoid injury to nerves and blood vessels in the surrounding area Grp1 was covered with hydrogel dressing PAUL HARTMANN AG Germany and replaced 2-3 times a week with topical mupirocin ointment three times a day Grp2 received photodynamic therapy only Grp3 accepted PDT then coated with hydrogel dressing as mentioned above The treatment protocol of PDT is described as follows after thorough debridement ALA Shanghai Fudan-Zhang jiang Bio-Pharmaceutical Co Ltd China in an oil-in-water emulsion was smeared on the wound After covering with dark plastic film for 3h the wounds were illuminated by a light-emitting diode LED red light Shenzhen Lifotronic Technology Co Ltd China After the operation a cold ice compress can be used to relieve the swelling and pain Then the hydrogel was uniformly applied to the wound and its surroundings Grp3 Grp2 and Grp3 received PDT at an interval of ten days for 4 sessions In all groups treatment responses and adverse reactions were recorded All patients received the treatment as mentioned above and then evaluated the clinical outcome After the end of the treatment all patients returned for follow up at weeks 2 4 8 and 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None