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CompletedNCT02011802SORKYSAUpdated Jan 20, 2026

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

An interventional study of Algosteril TM and Sorbact TM in Sinus Pilonidal, sponsored by University Hospital, Strasbourg, France. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
251
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sinus Pilonidal

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Keywords

  • Sorbact TM
  • Alginates
  • Dressing
  • Wound healing
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's enrollment of 251 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Man or woman over 18 years old
  • 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

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 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
251 participants (actual)

Study arms

  • 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

Interventions

  • DeviceAlgosteril TM
  • DeviceSorbact TM
06

What researchers measure

Primary outcomes

  1. Percentage of wounds healed

    Time frame: 75 days after surgery

Secondary outcomes

  1. Total surface area measure of non-healed wounds

    Time frame: 75 days after surgery

  2. VAS pain

    Time frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

  3. analgesic use

    Time frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

  4. antibiotics use

    Time frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

  5. number of dressings used

    Time frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

07

Study locations

4 sites
  • Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
    Colmar, 68024, France
  • Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
    Mulhouse, 68100, France
  • Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
    Saverne, 67700, France
  • Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France
    Strasbourg, 67091, France
08

References and documents

Publications

  • Romain B, Mielcarek M, Delhorme JB, Meyer N, Brigand C, Rohr S; SORKYSA group. Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study). BJS Open. 2020 Apr;4(2):225-231. doi: 10.1002/bjs5.50259. Epub 2020 Feb 4. PubMed 32020765 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2013 to primary completion in Sep 2017, 45 months.

Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 45 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2013
First posted
Dec 13, 2013
StartActual
Dec 2013
Primary completionActual
Sep 1, 2017
CompletionActual
Sep 1, 2017
Last update
Jan 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02011802
Collaborators
INRESA Pharma
Responsible party
Sponsor
First posted
Dec 13, 2013
Start date
Dec 2013
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Last update
Jan 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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