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

July 23, 2022 updated by: Sebastiano Biondo

RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Bellvitge University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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
1 year
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
1 year
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.
1 year
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.
1 year
Adverse effects related to the treatments
Time Frame: 1 year
Reported adverse effects
1 year
Cost effectiveness
Time Frame: 1 year
Cost effectiveness of NPT
1 year
Disease recurrence at follow-up
Time Frame: 1 year
Disease recurrence will be assessed 1 year after surgery.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebastiano Biondo

Collaborators

Hospital Universitari de Bellvitge

Investigators

  • Study Chair: Sebastiano Biondo, MD, Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICPS020/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Heal

Clinical Trials on Conventional wound care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe