Sinus Pilonidal Clinical Trial
— SORKYSAOfficial title:
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
| Verified date | November 2017 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 251 |
| Est. completion date | September 1, 2017 |
| Est. primary completion date | September 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France | INRESA Pharma |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of wounds healed | 75 days after surgery | ||
| Secondary | Total surface area measure of non-healed wounds | 75 days after surgery | ||
| Secondary | VAS pain | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first | ||
| Secondary | analgesic use | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first | ||
| Secondary | antibiotics use | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first | ||
| Secondary | number of dressings used | every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first |