Sinus Pilonidal
Conditions
Keywords
Sorbact TM, Alginates, Dressing, Wound healing
Brief 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. 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.
Interventions
DEVICEAlgosteril TM
DEVICESorbact TM
Sponsors
University Hospital, Strasbourg, France
INRESA Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of wounds healed | 75 days after surgery |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed