ENVELOP: Wondverzorging na een operatie aan de pilonidale sinus (ENVELOP)
Excisie en wondtherapie met negatieve druk versus excisie en open laten met standaard wondverzorging voor de behandeling van chronische sinusitis - een gerandomiseerde gecontroleerde studie
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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Sean T Martin
- Telefoonnummer: (01) 261 4037
- E-mail: seanmartin@rcsi.ie
Studie Contact Back-up
- Naam: Eanna Ryan
- Telefoonnummer: (01) 261 4037
- E-mail: eannaryan@rcsi.com
Studie Locaties
-
-
-
Castlebar, Ierland
- Werving
- Mayo University Hospital
-
Contact:
- Kevin Barry
-
Dublin, Ierland
- Werving
- Tallaght University Hospital
-
Contact:
- Dara Kavanagh
-
Dublin, Ierland, D09V2N0
- Werving
- Beaumont Hospital
-
Contact:
- John Burke
-
Dublin, Ierland
- Werving
- St James's Hospital
-
Contact:
- Michael Kelly
-
Dublin, Ierland
- Werving
- St Michael's Hospital, Dún Laoghaire
-
Contact:
- Helen Heneghan
-
Dublin, Ierland
- Werving
- St Vincent's Univeristy Hospital
-
Contact:
- Eanna Ryan
-
Kilkenny, Ierland
- Werving
- St. Luke's Hospital
-
Contact:
- Cathy Cronin
-
Limerick, Ierland
- Werving
- University Hospital Limerick
-
Contact:
- Colin Peirce
-
Tullamore, Ierland
- Werving
- Midlands University Hospital
-
Contact:
- Sean Johnston
-
Waterford, Ierland
- Werving
- University Hospital Waterford
-
Contact:
- Peter Neary
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy. |
Following elective excision of chronic pilonidal sinus disease with the wound left open, NPWT is applied in theatre using a polyurethane foam-based system (e.g. VAC, Renasys-GO, Prevena or equivalent) cut to fit the wound cavity, sealed with an adhesive drape and connected to a portable pump at -125 mmHg continuous pressure. Dressings are changed every 48-72 hours in clinic until granulation reaches skin level, followed by standard dressings until epithelialisation. |
|
Actieve vergelijker: Standard wound care (SWC)
Following excision, the wound is left open (no primary closure) and managed with standard dressings according to local protocol, with wound healing by secondary intention. |
Standard wound care |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to complete wound healing
Tijdsspanne: Up to 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. |
Up to 6 months post surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Measure of post operative pain
Tijdsspanne: Day of surgery, 28 days post surgery & 3 months post surgery
|
Pain measured by visual analogue pain scale (0 = no pain, 10 = worst pain) at rest, on walking and on sitting |
Day of surgery, 28 days post surgery & 3 months post surgery
|
|
Measure of post operative complications
Tijdsspanne: 6 months post surgery
|
Post-operative complications, including surgical site infection (CDC criteria), seroma, abscess, readmission and return to theatre. |
6 months post surgery
|
|
To compare recurrence rates
Tijdsspanne: 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 |
6 months post surgery
|
|
Cost-effectiveness
Tijdsspanne: 6 months post surgery
|
Within-trial cost-utility analysis from health-system and patient perspectives, expressed as incremental cost per QALY gained (QALYs from EQ-5D-5L, area under the curve). Resource use includes hospital and community contacts, dressing changes, complications, readmissions and returns to theatre, valued at Irish unit costs; patient costs and productivity losses via CoPaQ. |
6 months post surgery
|
|
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Tijdsspanne: Baseline, 1 month, 3 months & 6 months
|
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. Index values derived using the EQ-5D-5L value set specified in the Statistical Analysis Plan (Irish value set where available). |
Baseline, 1 month, 3 months & 6 months
|
|
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Tijdsspanne: 28 days, 3 months, 6 months
|
The POSAS is made up of two scales: the patient and observer scales each comprise six items scored 1 to 10; each scale is summed (6 = normal, 60 = worst) and reported separately. |
28 days, 3 months, 6 months
|
|
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Tijdsspanne: 28 days, 3 months, 6 months
|
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
28 days, 3 months, 6 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Sean T Martin, St. James's Hospital, Ireland
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RCSI-ENVELOP
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .