ENVELOP: Wound Care Following Pilonidal Sinus Surgery (ENVELOP)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Wound Healing; Pilonidal Sinus
• Intervention / Treatment: Device: Negative Pressure Wound Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean T Martin; Phone Number: (01) 261 4037; Email: seanmartin@rcsi.ie
• Study Contact Backup: Name: Eanna Ryan; Phone Number: (01) 261 4037; Email: eannaryan@rcsi.ie

Study Locations

• Ireland
  • Castlebar, Ireland
    • Not yet recruiting
    • Mayo University Hospital
    • Contact: Kevin Barry
  • Cork, Ireland
    • Not yet recruiting
    • University Hospital Cork
    • Contact: Peader Waters
  • Dublin, Ireland
    • Not yet recruiting
    • Tallaght University Hospital
    • Contact: Dara Kavanagh
  • Dublin, Ireland, H91 YR71
    • Not yet recruiting
    • Beaumont Hospital
    • Contact: John Burke
  • Dublin, Ireland
    • Not yet recruiting
    • St Michael's Hospital Dun Laoighre
    • Contact: Helen Heneghan
  • Galway, Ireland
    • Not yet recruiting
    • University Hospital Galway
    • Contact: Aisling Hogan
  • Kilkenny, Ireland
    • Not yet recruiting
    • St. Luke's Hospital
    • Contact: Cathy Cronin
  • Limerick, Ireland
    • Not yet recruiting
    • University Hospital Limerick
    • Contact: Colin Peirce
  • Tullamore, Ireland
    • Not yet recruiting
    • Midlands University Hospital
    • Contact: Sean Johnston
  • Waterford, Ireland
    • Recruiting
    • University Hospital Waterford
    • Contact: Peter Neary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy; The wound is dressed using negative pressure wound therapy.	Device: Negative Pressure Wound Therapy; Application of a negative wound pressure therapy dressing to the wound post laparotomy
Active Comparator: Standard Wound dressing; After the skin is closed, the wound is covered using sterile standard gauze dressing.	Device: Negative Pressure Wound Therapy; Application of a negative wound pressure therapy dressing to the wound post laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete wound healing	Number of days to complete epithelialisation or closure of the wound without any discharge, drainage, scab, and/or the requirement for further dressing. The quality of wound healing will be assessed using a validated patient and observer reported scar assessment tool-POSAS.	6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of post operative pain	Pain measured by visual analogue pain scores which is a scale from 1 (no pain) to 10 (worst pain), between the NPWT and SWC Groups.	6 months post surgery
Measure of post operative complications	Measure of post operative complications between the NPWT and SWC Groups	6 months post surgery
Measure of quality of life	To compare quality-of-life differences between the two groups from the time of surgery until wound healing is achieved using the	6 months post surgery
To investigate resource use	To investigate resource use and thereby cost effectiveness of NPWT versus standard wound care	6 months post surgery
To compare recurrence rates	To compare the 6-month recurrence rates (recurrence being defined as the development of a new sinus or abscess within the natal cleft occurring after wound healing had been achieved) between the NPWT and SWC Groups	6 months post surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	1 month
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	3 months
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	6 months
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6	1 month
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6	3 months
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6	6 months
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	1 Month
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	3 Months
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	6 Months
Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings	Investigating resource use and cost effectiveness of single-use, prophylactic negative pressure wound therapy versus standard dressings for midline laparotomy wounds based on length of hospital stay and costs of dressings	6 Months
Visual pain score questionnaire	Measurement of pain intensity	Day of Surgery
Visual pain score questionnaire	Measurement of pain intensity	1 Month
Visual pain score questionnaire	Measurement of pain intensity	3 Months

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Sean T Martin, St. James's Hospital, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 27, 2027

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Negative Pressure Wound Therapy; Pain Score; Health Economics; EQ-5D-5L; POSAS; Post-operative Complications; CoPaQ
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Wounds and Injuries; Pilonidal Sinus
• Other Study ID Numbers: RCSI-ENVELOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No