Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450015
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Comparison of Vacuum Assisted Closure and Saline Dressing in Patients With Diabetic Foot Ulcers
Sponsor:
Children Hospital and Institute of Child Health Lahore
Organization:
Children Hospital and Institute of Child Health Lahore
Study Overview
Official Title:
Comparison of Vacuum Assisted Closure and Saline Dressing in Patients With Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Conventionally diabetic foot is treated with moist wound dressing and antibiotics but recent studies show that VAC dressing gives better results as compared to conventional saline dressing in treating Diabetic Foot Ulcers This may decrease amputations rate work load on hospitals hospital stay repeated hospital admissions unemployment and can improve patients quality of life Objective of the study was to compare the effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers in terms of granulation tissue formation and wound healing
Detailed Description:
it was a randomized Controlled Trial done in department of Surgery Mayo HospitalvLahore Pakistan from January 2022 to July 2022 Patients divided in two groups in the VAC group Group A the wound bed was filled with a saline soaked gauze piece after it is thoroughly cleaned VAC was applied by placing sterile pads in two layers with a 16Fr Ryles tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet The tube was connected to a wall mounted suction device and the pressure was set at -125 mmHg In the Saline group Group B normal saline dressing was given This consists of placing a saline soaked gauze piece over the wound bed after cleaning the wound Patients were assessed and followed for wound healing The primary outcome parameter was time taken to complete wound healing Secondary outcome parameters were granulation tissue formation using a visual score and complication of bleeding pain and infection Only healthy granulation tissue which appears pink was considered for scoring assessment Infection was assessed by wound culture sensitivity which was sent every week
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