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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sinus Pilonidal

Intervention / Treatment
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* Device: Algosteril TM
* Device: Sorbact TM


Participation Criteria
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Eligibility Criteria
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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: Asymptomatic or discovered by the patient during a routine examination With chronic recurrent infection and skin rupture 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Algosteril TM<br>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<br> <br> |
| Experimental: Sorbact TM<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of wounds healed |  | 75 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sorbact TM, Alginates, Dressing, Wound healing