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| Name | Class |
|---|---|
| INRESA Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algosteril TM | Device |
| ||
| Sorbact TM |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of wounds healed | 75 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total surface area measure of non-healed wounds | 75 days after surgery | |
| VAS pain | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first | |
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Inclusion Criteria:
Man or woman over 18 years old
Informed consent signed by the participant
Affiliation to social security system
Having a pilonidal sinus:
Exclusion Criteria:
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32020765 | Result | 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. |
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| analgesic use |
| every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first |
| antibiotics use | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first |
| number of dressings used | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first |
| 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 |