De-roofing and Curettage vs WLE for Pilonidal Abscess

NCT03415347 | Unknown DMC

• 1 other identifier: 241937
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pilonidal disease refers to a common disease affecting mostly young males. It may present as asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There are many treatment options for the latter two manifestations but broadly speaking the surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision and drainage, (2) de-roofing and curettage and (3) wide local excision. The evidence available for the surgical management of acute pilonidal abscess is limited. Previous studies have consistently demonstrated that incision and drainage results in high recurrence rates and should not be considered as the first-line treatment option for the management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing with curettage or wide local excision should be considered as the surgical procedure of choice in acute pilonidal abscess. There has not been a prospective randomised study comparing abscess de-roofing with curettage and wide local excision for acute pilonidal abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation but has acceptable post-operative pain, complications and time to complete wound healing.

Conditions

Pilonidal Abscess; Pilonidal Sinus With Abscess; Pilonidal Sinus Infected; Pilonidal Disease

Keywords

Pilonidal abscess; Pilonidal disease; Pilonidal sinus

Outcome Measures

Primary Outcomes (1)

• Recurrence of pilonidal abscess

  During the follow up period the primary outcome measure will be if the patient develops a (recurrent) pilonidal abscess. This is a clinical diagnosis made by the clinician (General Practitioner or Hospital Doctor) attending to the patient. The definition for recurrent pilonidal abscess is any pilonidal abscess that occurs requiring either antibiotic (oral or intravenous) or surgical treatment. A small amount of discharge that settles on its own without the need for such treatment will not be counted as a recurrence.

  1 year

Secondary Outcomes (8)

• Time to complete wound healing

  4-10 weeks

• Return to work

  2-8 weeks

• Procedural time

  1 hour

• Wound size at operation

  1 hour

• Wound size over time

  4-10 weeks

Study Arms (2)

Abscess de-roofing and curettage

ACTIVE COMPARATOR

Abscess de-roofing and curettage. The patient will be placed in the lateral position with the buttocks spread apart using tape. The cleft of the buttocks will be shaved prior to cleaning and preparation of the skin. A spindle-shaped (elliptical) excision will be performed to the lateral aspect of the abscess formation with a scalpel staying away from the midline. Once the pus has been drained through this lateral incision the wound cavity will then be curetted and washed out with hydrogen peroxide. The wound size will be measured by the operating surgeon who will record the maximal length and width of the wound. Once haemostasis (cessation of any bleeding) is achieved the wound will be packed with Kaltostat ribbon and the wound dressed with blue gauze and mefix tape. The wound is therefore left open.

Procedure: Abscess de-roofing and curettage

Abscess wide local excision

ACTIVE COMPARATOR

Wide local excision. Patients will be placed in the prone position with the buttocks spread apart using tape. The cleft of the buttocks will be shaved prior to cleaning and preparation of the skin. Diluted methylene blue will be injected in all visible pits and a wide spindle-shaped (elliptical) midline excision of the skin and the underlying subcutaneous tissue down to the coccygeal (pre-sacral) fascia including all sinuses will be performed with electrocautery. The specimen will be sent for histology as per routine surgical practice. The wound will be washed with hydrogen peroxide. The wound size will be measured by the operating surgeon who will record the maximal length and width of the wound. Once haemostasis (cessation of any bleeding) is achieved the wound will be packed with Kaltostat ribbon and the wound dressed with blue gauze and mefix tape. The wound is therefore left open.

Procedure: Abscess wide local excision

Interventions

Abscess de-roofing and curettage PROCEDURE

Abscess de-roofing and curettage

Abscess de-roofing and curettage

Abscess wide local excision PROCEDURE

Abscess wide local excision

Abscess wide local excision

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with acute pilonidal abscess

You may not qualify if:

• Patients under the age of 16 years will be excluded.
• Immunocompromised (diabetes mellitus, taking oral steroids or immunosuppressive medication) patients will be excluded.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Related Publications (5)

• Loganathan A, Arsalani Zadeh R, Hartley J. Pilonidal disease: time to reevaluate a common pain in the rear! Dis Colon Rectum. 2012 Apr;55(4):491-3. doi: 10.1097/DCR.0b013e31823fe06c. No abstract available.

  PMID: 22426275 BACKGROUND

• Hosseini SV, Bananzadeh AM, Rivaz M, Sabet B, Mosallae M, Pourahmad S, Yarmohammadi H. The comparison between drainage, delayed excision and primary closure with excision and secondary healing in management of pilonidal abscess. Int J Surg. 2006;4(4):228-31. doi: 10.1016/j.ijsu.2005.12.005. Epub 2006 May 22.

  PMID: 17462356 BACKGROUND

• Vahedian J, Nabavizadeh F, Nakhaee N, Vahedian M, Sadeghpour A. Comparison between drainage and curettage in the treatment of acute pilonidal abscess. Saudi Med J. 2005 Apr;26(4):553-5.

  PMID: 15900358 BACKGROUND

• Eryilmaz R, Sahin M, Alimoglu O, Kaya B. [The comparison of incision and drainage with skin excision and curettage in the treatment of acute pilonidal abscess]. Ulus Travma Acil Cerrahi Derg. 2003 Apr;9(2):120-3. Turkish.

  PMID: 12836108 BACKGROUND

• Fahrni GT, Vuille-Dit-Bille RN, Leu S, Meuli M, Staerkle RF, Fink L, Dincler S, Muff BS. Five-year Follow-up and Recurrence Rates Following Surgery for Acute and Chronic Pilonidal Disease: A Survey of 421 Cases. Wounds. 2016 Jan;28(1):20-6.

  PMID: 26824973 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Curettage

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Lalin Navaratne, MBBS MRCS

  LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lalin Navaratne, MBBS MRCS

CONTACT

+447754056370; lalin.navaratne@nhs.net

Kamran Qurashi, MBBS FRCS

CONTACT

+447985483242; k.qurashi@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to one of two groups, intervention 1 (abscess de-roofing and curettage) or intervention 2 (abscess wide local excision), then followed up for 1 year to detect recurrence rate of pilonidal abscess

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 30, 2018
• Study Start: May 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 19, 2018

Record last verified: 2018-01