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PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY. (SINUS-TPN)

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ClinicalTrials.gov Identifier: NCT05474911
Recruitment Status : Recruiting
First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Collaborator:
Hospital Universitari de Bellvitge
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge

Study Description
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Brief Summary:

Pilonidal Sinus PS is a prevalent disease in young patients. There is currently no consensus on the surgical treatment of choice. Each method is associated with different advantages and disadvantages, as well as different recurrence rates. The ideal treatment should reduce morbidity, be associated with a short hospital stay (outpatient surgery), promote rapid healing, early return to work, and have a low recurrence rate. To date, no technique meets all these criteria. However, the NPT could meet them. The use of NPT in PS could decrease healing time, achieving an early return to work. In addition, it would avoid the need for daily dressings, which would mean lower hospital costs. However, the location of the wound (sacrum) and its proximity to the anal margin mean that its use cannot be generalized.

Although two retrospective series have recently reported good results with the use of NPT in PS, a prospective, randomized study is needed to compare healing time, recurrence rates, hospital costs, and assess quality of life for determine if this could be the treatment of choice.

Although NPT is commonly used in clinical practice (being useful in closing complex wounds, with devitalized tissues, burns and wounds with exposed tendons), to date there is not enough evidence to support its use after flattening the PS and it is for this reason that we conducted this study.

In this project there is a total absence of commercial interest in the proposal. No project related to the proposed one is currently being carried out.


Condition or disease Intervention/treatment Phase
Pilonidal Sinus Wound Heal Device: Negative pressure therapy Other: Conventional wound care Not Applicable

Detailed Description:

The study population will be made up of all patients with PS admitted to the General and Digestive Surgery service of the Hospital Universitari de Bellvitge from the start of the trial until the end of recruitment, and who meet the inclusion criteria.

Once the patients belonging to the population of interest have been identified, they will propose to participate in the clinical trial, providing complete information, as well as an information sheet with the details of the study. If you agree, the informed consent document will be provided for your signature and randomization will proceed.

Bitter et al. observed in a prospective study that the use of NTP did not reduce healing time compared to conventional closure 84 days (34-349) vs 93 days (43-264); p=0.44. However, the duration of NPT application of only 2 weeks might have been too short to see an adequate effect. Also, the small sample size could have influenced the results. On the other hand, recent publications on the use of TPN in the treatment of pilonidal sinus have shown a significant reduction in healing time (28 days) with minimal complications and adequate patient satisfaction. Taking into account the scarce evidence of the studies cited, we have decided to adopt a conservative criterion, assuming a smaller difference in time to healing between the two treatments (35 days).

To calculate the sample size, the time variable has been transformed into a logarithm. Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 94 patients, 47 subjects in the control group and 47 in the experimental group, are needed to detect a difference of 0.77. A common standard deviation of 1.26 is assumed. A rate of loss to follow-up of 10% has been estimated.

Randomization 1:1 will be performed using a statistical program at the baseline visit in outpatient clinics 48 hours after surgery, after assessing the dimensions of the wound, checking whether the participant meets the inclusion/exclusion criteria and has signed the informed consent.

For the purposes of the study and in order not to influence the type of surgery performed on patients with PS, only those patients who have undergone a flattening will be included. The 1st cure will be performed 24 hours later in the area outpatient clinic and will consist of removing the dressing, washing with physiological serum and placing a dry dressing.

48 hours after surgery, patients will be evaluated in outpatient clinics at our hospital. The dressing will be removed from the wound and after washing with serum, it will be checked if the patient meets the inclusion criteria. If you meet them, you will be offered to participate in the study and once you have signed the informed consent, randomization will proceed.

The patients will be monitored in person in outpatient clinics (CEX) by two members of the research team, made up of a nurse specialized in cures and a doctor specialized in surgery.

During the follow-up visits, a conventional dressing will be performed or the negative pressure system will be changed. Symptomatology and quality of life data will be collected through validated surveys.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Conventional care Other: Conventional wound care
The wound will be cleaned with physiological serum irrigation, the cavity will be dried with gauzes and filled with a dressing made of cellulose and silver. A skin protection spray will be applied to avoid irritation of the skin around the wound due to the adhesive of the dressing.
Experimental: Negative pressure therapy Device: Negative pressure therapy
The wound will be cleaned (irrigation with Physiological Serum), the cavity and the perilesional area will be dried with gauze. A skin protection spray will be applied to avoid irritation of the skin around the wound due to the adhesive of the dressing. The cavity will be filled with a sponge. When the depth of the wound is less than 1.5 cm, it will not be necessary to fill the defect. The appropriate dressing will be applied to the size of the incision, reinforcing the edges, and it will be connected to the TPN device, ensuring correct functionality.


Outcome Measures
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Primary Outcome Measures :
  1. Cicatrization [ Time Frame: 1 year ]
    Time in days from surgery to complete epithelialization of the wound, assessed by the dressing nurse and surgeon.


Secondary Outcome Measures :
  1. Wound size [ Time Frame: 1 year ]
    Defined as wound volume measured in milliliters. In addition, the measurements of width, length and depth in cm will be collected.

  2. Postoperative pain [ Time Frame: 1 year ]
    Evaluated with the visual analog pain scale ranging from 0 to 10, where 0 represents no pain and 10 represents intolerable pain. It will be assessed weekly

  3. Time of incorporation into daily activities [ Time Frame: 1 year ]
    Time in days from surgery to incorporation into daily activities as reported by the patients in the weekly evaluation

  4. Patient quality of life [ Time Frame: 1 year ]
    Evaluated by applying the SF-36 questionnaire in both groups at 15 days, 30 days, and monthly until healing. A total score will be calculated in each of the 8 sections and converted to a scale from 0 to 100, with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.

  5. Patient satisfaction [ Time Frame: 1 year ]
    Reported by the patient on a scale of 0 to 10, where 0 corresponds to "totally unsatisfactory" and 10 corresponds to "totally satisfactory". The score obtained at the end of healing will be recorded. It will be done when healing is complete.

  6. Adverse effects related to the treatments [ Time Frame: 1 year ]
    Reported adverse effects

  7. Cost effectiveness [ Time Frame: 1 year ]
    Cost effectiveness of NPT

  8. Disease recurrence at follow-up [ Time Frame: 1 year ]
    Disease recurrence will be assessed 1 year after surgery.


Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients diagnosed with SP (recurrence or not), who have undergone surgery.
  • Minimum depth of the wound 1.5 cm.

Exclusion Criteria:

  • Inferior margin of the surgical wound is located less than 3 cm from the anus
  • Patients under 16 years of age
  • Unable to track
  • Diagnosed psychiatric illness
  • Patients diagnosed with hidradenitis
  • Uncontrolled diabetics
  • Immunocompromised (kidney or liver transplant, chronic treatment with corticosteroids, haematological disease, neoplastic disease undergoing chemotherapy)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05474911


Contacts
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Contact: Ana Gálvez Saldaña +34 932607500 ana.galvez@bellvitgehospital.cat
Contact: Domenico Fraccalvieri +34 932607500 domenico@bellvitgehospital.cat

Locations
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Spain
Bellvitge University Hospital Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Sebastiano Biondo, MD, PhD    +34 932607485    sbn.biondo@gmail.com   
Sponsors and Collaborators
Sebastiano Biondo
Hospital Universitari de Bellvitge
Investigators
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Study Chair: Sebastiano Biondo, MD Hospital Universitari de Bellvitge
More Information
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Publications:

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Responsible Party: Sebastiano Biondo, PhD, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT05474911    
Other Study ID Numbers: ICPS020/22
First Posted: July 26, 2022    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:
Negative presure therapy
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms