Pilonidal Sinus, Wound Healing
Conditions
Keywords
Negative Pressure Wound Therapy, Surgical Site Infection, Post-operative Complications, Health Economics, POSAS, CoPaQ, EQ-5D-5L, Pain Score
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 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.
Interventions
DEVICENegative Pressure Wound Therapy
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound healing | 6 months post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of post operative pain | 6 months post surgery | 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. |
| Measure of post operative complications | 6 months post surgery | Measure of post operative complications between the NPWT and SWC Groups |
| Measure of quality of life | 6 months post surgery | To compare quality-of-life differences between the two groups from the time of surgery until wound healing is achieved using the |
| To investigate resource use | 6 months post surgery | To investigate resource use and thereby cost effectiveness of NPWT versus standard wound care |
| To compare recurrence rates | 6 months post surgery | 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 |
| Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) | 1 month | 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) |
| Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) | 1 month | 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 |
| Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) | 1 Month | The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
| Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings | 6 Months | 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 |
| Visual pain score questionnaire | Day of Surgery | Measurement of pain intensity |
Countries
Ireland
Contacts
CONTACTSean T Martin
CONTACTEanna Ryan
PRINCIPAL_INVESTIGATORSean T Martin
St. James's Hospital, Ireland
Outcome results
None listed