Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647290
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-11-28
Brief Title:
ENVELOP Wound Care Following Pilonidal Sinus Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Excision and Negative Pressure Wound Therapy Versus Excision and Leaving Open With Standard Wound Care for Management of Chronic Pilonidal Sinus Disease - A Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ENVELOP
Brief Summary:
This is a single-blinded multicentre prospective randomised controlled trial RCT comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy NPWT after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease PSD
Detailed Description:
Pilonidal sinus disease PSD is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft The definitive aetiology of the condition is unknown however it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue This results in infection abscess formation chronic discharge and pain PSD is a common condition affecting 26 per 10000 population with the prevalence reaching 11 in young adult males
PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery together with negative impacts on patients quality of life and self-image An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery
The objective of this multicentre national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD
PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery together with negative impacts on patients quality of life and self-image An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery
The objective of this multicentre national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD
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