None listed
Conditions
Brief summary
This is a prospective, randomised controlled trial comparing SNAP dressings, a type of negative-pressure wound therapy dressing, with standard wound dressings for patients aged 12-40 years undergoing an excision of a pilonidal sinus. Eligible patients (and for paediatric patients, their parents/guardians) will be approached for enrolment. Participants will then be randomised to have a SNAP dressing or standard wound dressing placed on the surgical wound after the pilonidal sinus has been excised and the wound primarily closed. Post-operatively, patients will be followed up on days 3, 7, 10 and 14 and then weekly in the Outpatients Clinic until the wound has healed to examine the wound. Follow-up will be conducted by a clinical nurse specialist or other member of the treating team. There will also be a follow-up 2 months and 6 months post-operatively. The study and patient follow-up will be assessing: 1. Rate of wound dehiscence (breakdown) in each group and assessment of progression of wound dehiscence using clinical photographs as evaluated by a blinded outcome assessor (clinical photographs only taken for wounds where a dehiscence has occurred) 2. Time taken for the wound to fully heal 3. Rate of disease recurrence within 6 months post-operatively 4. Analgesia requirements for the wound 5. Ratio of wound size two weeks post-operatively compared to at the time of surgery 6. Patient satisfaction with the dressing and wound healing and quality of life survey 2 months post-operatively 7. Patient phone/email questionnaire regarding disease recurrence and progress 6 months post-operatively 8. Time taken to resume normal activities For patients randomised to have a standard dressing (i.e. no SNAP dressing) who have a wound dehiscence, the endpoint for this trial would have met. For these patients, some will receive a SNAP dressing as determined by the treating team for further management of the dehisced wound. We will compare wound healing and assess outcomes in these patients with patients who go on to have further management with a standard dressing. This study will thus be aiming to establish whether the use of a negative wound pressure therapy dressing (SNAP dressing) improves wound healing, the rate of wound dehiscence, recurrence rates and patients’ quality of life and return to normal activities compared to a standard wound dressing.
Interventions
Negative-pressure dressing (SNAP dressing)
Following excision of the pilonidal sinus and primary closure of the wound with sutures, an appropriately-sized SNAP dressing will placed on the closed wound at the end of the operation in the operating theatre. This dressing will remain in place for 14 days post-operatively or until it comes off itself. The dressing will be applied by a clinical nurse specialist or other member of the treating team appropriately trained in the application of these dre
Negative-pressure dressing (SNAP dressing) Following excision of the pilonidal sinus and primary closure of the wound with sutures, an appropriately-sized SNAP dressing will placed on the closed wound at the end of the operation in the operating theatre. This dressing will remain in place for 14 days post-operatively or until it comes off itself. The dressing will be applied by a clinical nurse specialist or other member of the treating team appropriately trained in the application of these dressings. During the follow-up appointments in the Outpatients Clinic in the first 14 days (on days 3, 7, 10 and 14), the dressing will be reviewed by the clinical nurse specialist or member of the treating team and, if required, adjusted to ensure it is correctly placed. The SNAP dressing will have two components - the dressing itself and the small pump attached to it which creates a negative pressure environment under the dressing. The degree of negative pressure administered by the dressing will be -125mmHg.
Sponsors
Department of Paediatric Surgery, Monash Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Patients aged between 12 and 40 years presenting to Monash Children’s Hospital, Monash Medical Centre, Dandenong Hospital, Casey Hospital, The Royal Children's Hospital and Box Hill Hospital with a symptomatic pilonidal sinus (+/- pilonidal abscess) requiring surgical excision.
Exclusion criteria
Age <12 years or age >40 years Significant medical comorbidity (e.g. diabetes, inflammatory bowel disease, immunodeficiency) Previously excised pilonidal sinus Pilonidal sinus <2cm from the anal verge Inability to attend follow-up appointments
Outcome results
None listed