Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
NCT ID: NCT02011802
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
251 participants
INTERVENTIONAL
2013-12-31
2017-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Algosteril TM
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.
Sorbact TM
Interventions
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Algosteril TM
Sorbact TM
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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INRESA Pharma
INDUSTRY
University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
Colmar, , France
Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
Mulhouse, , France
Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
Saverne, , France
Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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5568
Identifier Type: -
Identifier Source: org_study_id