Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision (SORKYSA)
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:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision|
- Percentage of wounds healed [ Time Frame: 75 days after surgery ]
- 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 ]
|Actual Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011802
|Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté|
|Colmar, France, 68024|
|Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec|
|Mulhouse, France, 68100|
|Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne|
|Saverne, France, 67700|
|Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France|
|Strasbourg, France, 67091|