Trial Title:
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
NCT ID:
NCT06647290
Condition:
Pilonidal Sinus
Wound Healing
Conditions: Official terms:
Pilonidal Sinus
Wounds and Injuries
Conditions: Keywords:
Negative Pressure Wound Therapy
Surgical Site Infection
Post-operative Complications
Health Economics
POSAS
CoPaQ
EQ-5D-5L
Pain Score
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Negative Pressure Wound Therapy
Description:
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Arm group label:
Negative Pressure Wound Therapy
Arm group label:
Standard Wound dressing
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
10,000 population, with the prevalence reaching 1.1% 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
i) They are aged 18 years or older
ii) They are undergoing elective pilonidal sinus excision without primary closure
Exclusion Criteria:
i) They are unable to adhere to protocol requirements e.g. questionnaire completion
ii) They are undergoing emergency drainage for a pilonidal abscess
iii) They are undergoing surgery for a pilonidal sinus disease in locations other than
the natal cleft
iv) They have underlying osteomyelitis
v) They have underlying fistulating disease e.g. Crohn's
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo University Hospital
Address:
City:
Castlebar
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Kevin Barry
Facility:
Name:
University Hospital Cork
Address:
City:
Cork
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Peader Waters
Facility:
Name:
Beaumont Hospital
Address:
City:
Dublin
Zip:
H91 YR71
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
John Burke
Facility:
Name:
St Michael's Hospital Dun Laoighre
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Helen Heneghan
Facility:
Name:
Tallaght University Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Dara Kavanagh
Facility:
Name:
University Hospital Galway
Address:
City:
Galway
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Aisling Hogan
Facility:
Name:
St. Luke's Hospital
Address:
City:
Kilkenny
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Cathy Cronin
Facility:
Name:
University Hospital Limerick
Address:
City:
Limerick
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Colin Peirce
Facility:
Name:
Midlands University Hospital
Address:
City:
Tullamore
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Sean Johnston
Facility:
Name:
University Hospital Waterford
Address:
City:
Waterford
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Peter Neary
Start date:
October 1, 2024
Completion date:
April 27, 2027
Lead sponsor:
Agency:
Royal College of Surgeons, Ireland
Agency class:
Other
Source:
Royal College of Surgeons, Ireland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06647290
