Sinus PilonidalSORKYSANCT02011802
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
A study testing Algosteril TM and Sorbact TM in people with Sinus Pilonidal, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Pilonidal
- What is being tested?
- Algosteril TM and Sorbact TM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2013to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known for intolerance to one of the dressings
- Known pregnancy
- Uncontrolled diabetes (fasting glucose >2g/l)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
Colmar, 68024
Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
Mulhouse, 68100
Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
Saverne, 67700
Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France
Strasbourg, 67091
About this study
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.
- Conditions
- Sinus Pilonidal
- Being tested
- Algosteril TM, Sorbact TM
- Keywords
- Sorbact TM, Alginates, Dressing, Wound healing
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algosteril TMDevice
Sorbact TMDevice
| Study group | Role | What they receive |
|---|---|---|
| Algosteril TM | Active comparator | 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. Receives: Device: Algosteril TM |
| Sorbact TM | Experimental | 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. Receives: Device: Sorbact TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of wounds healed
Measured: 75 days after surgery
Secondary outcomes (5)
Total surface area measure of non-healed wounds
Measured: 75 days after surgery
VAS pain
Measured: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
analgesic use
Measured: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
antibiotics use
Measured: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
number of dressings used
Measured: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus PilonidalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- INRESA Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011802
- Sponsor's protocol ID
- 5568
- Acronym
- SORKYSA
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2013
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
- ClinicalTrials.gov ID
- NCT02011802
- Acronym / sponsor ID
- SORKYSA / 5568
- Conditions
- Sinus Pilonidal
- Keywords
- Sorbact TM, Alginates, Dressing, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- INRESA Pharma
- Study start
- Dec 2013 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algosteril TM | Active comparator | Device: Algosteril TMCalcium 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. |
| Sorbact TM | Experimental | Device: Sorbact TMDACC (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman over 18 years old
- Informed consent signed by the participant
- Affiliation to social security system
- Having a pilonidal sinus:
Key exclusion criteria (9 listed)
- Patients with concomitant pathology:
- Patients participating in another clinical trial
- Known for intolerance to one of the dressings
- Known pregnancy
- Uncontrolled diabetes (fasting glucose >2g/l)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algosteril TM | Device | Algosteril TM |
| Sorbact TM | Device | Sorbact TM |
Primary outcome
Percentage of wounds healed
Time frame: 75 days after surgery
5 secondary outcomes
Total surface area measure of non-healed wounds
Time frame: 75 days after surgery
VAS pain
Time frame: 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
antibiotics use
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 32020765Romain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algosteril TM and Sorbact TM in people with Sinus Pilonidal, run by University Hospital, Strasbourg, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of wounds healed (time frame: 75 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.