Clinical trial NCT02011802: Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
Official title: Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Pilonidal
Keywords: Sorbact TM
Alginates
Dressing
Wound healing
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: INRESA Pharma
First posted: 2013-12-13
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of wounds healed
timeFrame: 75 days after surgery
Secondary outcomes:
measure: Total surface area measure of non-healed wounds
timeFrame: 75 days after surgery
measure: VAS pain
timeFrame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
measure: analgesic use
timeFrame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
measure: antibiotics use
timeFrame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
measure: number of dressings used
timeFrame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
Other outcomes:
Locations:
city: Colmar
country: France
facility: Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
city: Mulhouse
country: France
facility: Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
city: Saverne
country: France
facility: Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France
Study officials:
References:
citation: 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.