PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.

NCT05474911 | Unknown DMC

• 1 other identifier: ICPS020/22
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Sinus; Wound Heal

Keywords

Negative presure therapy

Outcome Measures

Primary Outcomes (1)

• Cicatrization

  Time in days from surgery to complete epithelialization of the wound, assessed by the dressing nurse and surgeon.

  1 year

Secondary Outcomes (8)

• Wound size

  1 year

• Postoperative pain

  1 year

• Time of incorporation into daily activities

  1 year

• Patient quality of life

  1 year

• Patient satisfaction

  1 year

Study Arms (2)

Conventional care

ACTIVE COMPARATOR

Other: Conventional wound care

Negative pressure therapy

EXPERIMENTAL

Device: Negative pressure therapy

Interventions

Negative pressure therapy DEVICE

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.

Negative pressure therapy

Conventional wound care OTHER

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.

Conventional care

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sebastiano Biondo: lead
• Hospital Universitari de Bellvitge: collaborator

Study Sites (1)

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Sebastiano Biondo, MD

  Hospital Universitari de Bellvitge

  STUDY CHAIR

Central Study Contacts

Ana Gálvez Saldaña

CONTACT

+34 932607500; ana.galvez@bellvitgehospital.cat

Domenico Fraccalvieri

CONTACT

+34 932607500; domenico@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)