Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision (SORKYSA)

January 16, 2026 updated by: University Hospital, Strasbourg, France

Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).

The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

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 Locations

  • France
      • Colmar, France, 68024
        • Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
      • Mulhouse, France, 68100
        • Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
      • Saverne, France, 67700
        • Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
      • Strasbourg, France, 67091
        • Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Man or woman over 18 years old
  • Informed consent signed by the participant
  • Affiliation to social security system

  • Having a pilonidal sinus:

    • Asymptomatic or discovered by the patient during a routine examination
    • With chronic recurrent infection and skin rupture

Exclusion Criteria:

  • Patients with concomitant pathology:

    • cancer treated by chemotherapy
    • Hypertension uncontrolled systolic blood pressure>180 mmHg or diastolic> 110 mmHg
    • Severe comorbidity with reduced life expectancy less than 12 months
    • Acute cardiovascular disease (myocardial infarction, stroke, recent heart surgery) within 3 months before inclusion
  • Patients participating in another clinical trial
  • Known for intolerance to one of the dressings
  • Known pregnancy
  • Uncontrolled diabetes (fasting glucose >2g/l)

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: Algosteril TM
Calcium alginate dressings are made from seaweed. Calcium alginate dressings form a natural gel of the exudates against the healing tissue that keeps it moist and supple, aiding in healing and tissue growth. In addition, this gel material forms a natural barrier to bacteria that may complicate healing with secondary infections of the wound. Alginates are the reference of dressing after sinus pilonidal excision.
Device: Algosteril TM
Experimental: Sorbact TM
DACC (dialkylcarbamoyle chloride) is a main component of the bacterial binding wound dressing: Sorbact. DACC is a hydrophobic fatty acid derivative that can be used to coat dressing materials, resulting in a dressing with highly hydrophobic pathogen binding properties. This is a primary wound interface dressing and is effective when in close contact with the wound bed in a moist environment.
Device: Sorbact TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of wounds healed
Time Frame: 75 days after surgery
75 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Total surface area measure of non-healed wounds
Time Frame: 75 days after surgery
75 days after surgery
VAS pain
Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
analgesic use
Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
antibiotics use
Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
number of dressings used
Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Collaborators

INRESA Pharma

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 (Actual)

December 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimated)

December 13, 2013

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5568

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.

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