De-roofing and Curettage vs WLE for Pilonidal Abscess
De-roofing and Curettage vs WLE for Pilonidal Abscess
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.
BACKGROUND

 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.

 Some authors believe that the incision and drainage method is an effective procedure.
 However, this method would treat only the acute infection and produce the necessity of
 re-operation for definite therapy. The alternative method is wide local excision in which the
 patients receive definite therapy in a single staged operation reducing the number of
 operations per patient, patient visits to hospital and overall cost to the health service.
 However, concerns over the length of time to gain acceptable wound healing following wide
 local excision has decreased its popularity with some surgeons. There is limited evidence
 available for the surgical management of acute pilonidal abscess which has lead to
 disagreement as to what is the best option. One randomised study of 76 patients compared
 incision and drainage of acute pilonidal abscess followed by an elective excision of the
 pilonidal sinus and primary closure at 3 weeks versus wide local excision with the wound left
 open for secondary healing. At 12 months the incision and drainage followed by elective
 excision group had 14% recurrence of pilonidal abscess whereas the wide local excision group
 had 0% recurrence. Another randomised study of 131 patients compared incision and drainage
 versus abscess excision (de-roofing) with curettage for acute pilonidal abscess and found
 recurrence rates of 42% in the incision and drainage group verses 11% in the curettage group.
 A prospective randomised study similarly compared incision and drainage versus abscess
 excision (de-roofing) with curettage for acute pilonidal abscess and reported a significantly
 higher rate of developing a chronic pilonidal sinus in the incision and drainage group (76%
 vs 24%, p<0.001). A retrospective study with median follow up of 5.3 years has recently been
 published comparing abscess de-roofing with curettage and wide local excision for acute
 pilonidal abscess. The authors reported an approximate three-fold increase in recurrence rate
 in the curettage group compared with the wide local excision group.

 RATIONALE FOR CURRENT STUDY

 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.

 Research question:

 Does wide local excision when compared to abscess excision (de-roofing) with curettage result
 in reduced recurrence rates and therefore provide a single-stage procedure for the management
 of acute pilonidal abscess and the underlying causative sinus? Is wide local excision when
 compared to abscess de-roofing with curettage a safe procedure in terms of complications
 (bleeding, wound infection), post-operative pain and time to complete wound healing?

 Hypothesis:

 Wide local excision for the management of acute pilonidal abscess results in lower recurrence
 rates when compared with abscess de-roofing with curettage. Post-operative pain,
 complications and time to complete wound healing will not be significantly different between
 the two treatment groups.

 STUDY OBJECTIVES

 Primary objectives:

 To compare therapeutic values of abscess de-roofing with curettage versus wide local excision
 in the surgical treatment of patients with acute pilonidal abscess. Therapeutic values
 include: recurrence rate, post-operative pain, time to complete wound healing, time to
 returning to work or normal daily activities and complications of surgery (bleeding and wound
 infection).

 Secondary objectives:

 To assess the practicality of abscess de-roofing with curettage and wide local excision in
 the surgical treatment of patients with acute pilonidal abscess in terms of operative time
 and total time in theatre.

 STUDY DESIGN

 Type of study: Single centre randomised controlled clinical trial

 Study design:

 Patients with acute pilonidal abscess will be randomised into 2 treatment groups.
 Randomisation of patients will be performed by the surgical registrar on call for either
 admissions or the emergency theatre. The method of randomisation will be by identical sealed
 envelopes. The principle investigator (Lalin Navaratne) will create trial packs within
 identical sealed envelopes. These packs will contain:

 1. Patient information sheet (PIS)

 2. 3 copies of the patient consent form (for the study)

 3. A consent form for the operation (Consent Form 1)

 4. Information sheet to the operating surgeon outlining which treatment arm the patient has
 been allocated to

 5. The data collection sheet(s) for demographic data, medical history, smoking history,
 previous pilonidal disease history, operative data, and follow up data

 6. Letter to GP

 The sealed envelopes will be created in blocks of 20 (10 for each treatment arm) to keep the
 groups of similar size during the study. Once the 20 envelopes have been created and sealed
 (with a signed white label) they will be shuffled by another investigator who has not been
 involved in creating the packs and placed in a secure location (locked filing cabinet within
 the surgical assessment unit). When a patient has been referred to the emergency surgery unit
 they will be seen on the surgical assessment unit and will be invited to join the study if
 inclusion and exclusion criteria have been met. The patient will be given the Patient
 Information Sheet (PIS) and have adequate time to read it. Once the patient has read the PIS
 and had an opportunity to ask any questions they will be enrolled into the study if
 applicable. The surgeon will take the trial pack 'on the top of the pile' within the secured
 filing cabinet which will randomly allocate the patient to one of two treatment arms. The two
 treatment arms are: (1) de-roofing and curettage and (2) wide local excision. The surgeon
 will complete any data collection requirements at this stage and all documentation will
 remain in the envelope and be tracked with the patients notes.

 The two arms of this trial will be performed in the operating theatre with the patient under
 general anaesthesia. The surgical technique for each treatment arm is detailed below:

 1. 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.

 2. 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.

 Patients will not be routinely prescribed any antibiotics following the operation. All
 patients will have wound packing for the first 24 hours after the operation. For patients
 within the drainage and curettage group no further packing is usually required. Patients
 discharged the same day of surgery will have their packing removed and wound reviewed in the
 community. Patients who stay in-hospital overnight following their surgery will have their
 packing removed and wound reviewed in-hospital prior to discharge. For patients within the
 wide local excision group, packing may be required following the first post-operative day and
 packing is continued until no longer indicated. Dressing changes for these patients will
 occur in the community.

 All patients will be advised to cleanse the wounds in the shower at least once a day and will
 be followed up in a dedicated wound clinic weekly until their wounds have healed. After
 healing, they will be followed up in a telephone clinic at 6 and then 12 months. When
 attending the wound clinic, data will be collected on abscess recurrence, time to wound
 healing, number of days until the patient can return to work (or when they resumed normal
 daily activities), pain scores, wound size and any signs of wound infection. Further follow
 up in the main outpatient department will monitor for abscess recurrence. With patient
 consent, non-identifying photographs may be taken of the wound during the operation and the
 subsequent healing process during the follow up period.

 Any patient enrolled within the study may re-present with an acute abscess recurrence within
 the follow up period of one year. If the patient belongs to the de-roof and curettage group,
 they would be offered a wide local excision as the surgical management of choice. If the
 patient belongs to the wide local excision group, then they would be offered further drainage
 and curettage or wide local excision based on what the attending surgeon feels is the best
 surgical option for that particular patient. Analysis would be by intention to treat. Any
 patient re-operated on during the study period would not need to be followed up in the weekly
 wound clinic for the purposes of data collection (time to healing, time to returning to work,
 pain scores, wound size etc). These patients would be followed up in the outpatient clinic as
 per departmental standard operating procedures.
Inclusion Criteria:

 -  All patients with acute pilonidal abscess

 Exclusion Criteria:

 -  Patients under the age of 16 years will be excluded.

 -  Immunocompromised (diabetes mellitus, taking oral steroids or immunosuppressive
 medication) patients will be excluded.