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Trial registered on ANZCTR


Registration number
ACTRN12618000026224
Ethics application status
Approved
Date submitted
2/06/2017
Date registered
12/01/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Negative Pressure Dressing in Pilonidal Surgery
Scientific title
Effect of negative pressure dressing versus standard wound dressing on the rate of wound dehiscence in patients undergoing pilonidal surgery
Secondary ID [1] 292034 0
None
Universal Trial Number (UTN)
Trial acronym
N-PIPS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pilonidal disease 303427 0
Condition category
Condition code
Surgery 302839 302839 0 0
Surgical techniques
Skin 302961 302961 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298162 0
Treatment: Devices
Comparator / control treatment
Standard wound dressing
Following excision of the pilonidal sinus and primary closure of the wound with sutures, an appropriately-sized standard dressing will placed on the closed wound at the end of the operation in the operating theatre. The standard dressing used will be determined by the surgeon operating and will be one which is commonly used to cover an excised pilonidal sinus. 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.
Control group
Active

Outcomes
Primary outcome [1] 302231 0
Rate of wound dehiscence (breakdown) in each group as assessed by a clinical nurse specialist or other member of the treating team who will review the wound at each follow-up appointment to assess whether wound dehiscence has occurred
Timepoint [1] 302231 0
Within the first 6 months post-operatively
The presence of wound dehiscence will be assessed at the follow-up appointments (follow-up appointments will be on days 3, 7, 10 and 14 post-operatively and then weekly in the Outpatients Clinic until the wound has healed as well as follow-ups at 2 months post-operatively and phone/email follow-up at 6 months post-operatively).
Secondary outcome [1] 335241 0
Time taken for the wound to fully heal (days) as assessed by a clinical nurse specialist or other member of the treating team who will review the wound at each follow-up appointment to assess whether the wound has full healed
Timepoint [1] 335241 0
Within first 6 months post-operatively
The time taken for the wound to fully heal will be determined through the follow-up appointments (follow-up appointments will be on days 3, 7, 10 and 14 post-operatively and then weekly in the Outpatients Clinic until the wound has healed).
Secondary outcome [2] 335242 0
Rate of disease recurrence as assessed by a clinical nurse specialist or other member of the treating team who will review the wound at each follow-up appointment to assess whether disease has recurred
Timepoint [2] 335242 0
Within first 6 months post-operatively
Disease recurrence will be assessed at the follow-up appointments (follow-up appointments will be on days 3, 7, 10 and 14 post-operatively and then weekly in the Outpatients Clinic until the wound has healed as well as follow-ups at 2 months and and phone/email follow-up at 6 months post-operatively).
Secondary outcome [3] 335243 0
Analgesia requirements for the wound as reported by the patient as reported by the patient at each of the follow-up appointments and at the 2 month post-operative follow-up appointment using a question specifically designed for this study
Timepoint [3] 335243 0
As assessed at each follow-up appointment (follow-up appointments will be on days 3, 7, 10 and 14 post-operatively and then weekly in the Outpatients Clinic until the wound has healed) and at the 2-month post-operative follow-up appointment
Secondary outcome [4] 335244 0
Ratio of wound size (in centimetres) two weeks post-operatively compared to at the time of surgery as measured with a medical ruler at the end of the operation and at the 2-week follow-up appointment by a member of the treating team to determine the ratio of wound size.
Timepoint [4] 335244 0
At two weeks post-operatively
Secondary outcome [5] 335245 0
Patient satisfaction with the dressing and wound healing as assessed using a specialised questionnaire specifically designed for this study with questions which have been adapted from previous studies evaluating quality of life post-pilonidal surgery which patients will complete at the 2-month postoperative follow-up appointment. The questions for the survey have been adapted from:
1. Topuz Ö, Sözen S, Tükenmez M, Topuz S, Vurdem ÜE. Crystallized Phenol Treatment of Pilonidal Disease Improves Quality of Life. The Indian Journal of Surgery. 2014;76(1):81-84.
2. Ertan T., Koc M., Gocmen E., Aslar A.K., Keskek M., Kilic M. Does technique alter quality of life after pilonidal sinus surgery? American Journal of Surgery. 2005; 190(3):388-392.
3. SF-36 questionnaire
4. Cardiff Wound Impact Schedule
Timepoint [5] 335245 0
2 months post-operatively
Secondary outcome [6] 335246 0
Time taken to resume normal activities (days) as reported by the patient in the satisfaction and quality of life follow-up questionnaire which has been specifically designed for this study using questions which have been adapted from previous studies evaluating quality of life post-pilonidal surgery which patients will complete at the 2-month postoperative follow-up appointment. The questions for the survey have been adapted from:
1. Topuz Ö, Sözen S, Tükenmez M, Topuz S, Vurdem ÜE. Crystallized Phenol Treatment of Pilonidal Disease Improves Quality of Life. The Indian Journal of Surgery. 2014;76(1):81-84.
2. Ertan T., Koc M., Gocmen E., Aslar A.K., Keskek M., Kilic M. Does technique alter quality of life after pilonidal sinus surgery? American Journal of Surgery. 2005; 190(3):388-392.
3. SF-36 questionnaire
4. Cardiff Wound Impact Schedule
Timepoint [6] 335246 0
2 months post-operatively
Secondary outcome [7] 335671 0
Patient quality of life post-operatively as assessed using a specialised questionnaire which has been specifically designed for this study using questions which have been adapted from previous studies evaluating quality of life post-pilonidal surgery which patients will complete at the 2-month postoperative follow-up appointment. The questions for the survey have been adapted from:
1. Topuz Ö, Sözen S, Tükenmez M, Topuz S, Vurdem ÜE. Crystallized Phenol Treatment of Pilonidal Disease Improves Quality of Life. The Indian Journal of Surgery. 2014;76(1):81-84.
2. Ertan T., Koc M., Gocmen E., Aslar A.K., Keskek M., Kilic M. Does technique alter quality of life after pilonidal sinus surgery? American Journal of Surgery. 2005; 190(3):388-392.
3. SF-36 questionnaire
4. Cardiff Wound Impact Schedule
Timepoint [7] 335671 0
2 months post-operatively

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be achieved using an online randomisation software. At the time of the operation, the software will be used to randomly allocate the patient to one of the two treatment arms. Using this online system, in no way will a participating researcher be able to determine which group the software will randomise the patient to. Sealed opaque envelopes will not be used as the online randomisation software will be used in its place.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence used will be computer-generated with 50% of participants being allocated to each of the two intervention arms. The online randomisation software used will allocate 50% of participants to each of the two intervention arms. Randomisation will be stratified for age (age less than 18 years or age greater than or equal to 18 years), sex and BMI.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
13/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8118 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 8119 0
Casey Hospital - Berwick
Recruitment hospital [3] 8227 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 9184 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [5] 9478 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 12794 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 17820 0
3052 - Parkville
Recruitment postcode(s) [2] 18211 0
3128 - Box Hill
Recruitment postcode(s) [3] 25254 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [4] 16175 0
3168 - Clayton
Recruitment postcode(s) [5] 16284 0
3175 - Dandenong
Recruitment postcode(s) [6] 16176 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 296566 0
Hospital
Name [1] 296566 0
Department of Paediatric Surgery, Monash Children's Hospital
Country [1] 296566 0
Australia
Primary sponsor type
Hospital
Name
Department of Paediatric Surgery, Monash Children's Hospital
Address
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 295517 0
None
Name [1] 295517 0
Address [1] 295517 0
Country [1] 295517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297783 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 297783 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 297783 0
Australia
Date submitted for ethics approval [1] 297783 0
17/01/2018
Approval date [1] 297783 0
13/04/2018
Ethics approval number [1] 297783 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75098 0
Mr Ramesh Nataraja
Address 75098 0
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Rd.
Clayton VIC 3168
Country 75098 0
Australia
Phone 75098 0
+61385723838
Fax 75098 0
Email 75098 0
Ram.Nataraja@monashhealth.org
Contact person for public queries
Name 75099 0
Ramesh Nataraja
Address 75099 0
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC
Country 75099 0
Australia
Phone 75099 0
+61 3 8572 3838
Fax 75099 0
Email 75099 0
Ram.Nataraja@monashhealth.org
Contact person for scientific queries
Name 75100 0
Ramesh Nataraja
Address 75100 0
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC
Country 75100 0
Australia
Phone 75100 0
+61 3 8572 3838
Fax 75100 0
Email 75100 0
Ram.Nataraja@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.