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

Not Applicable

Completed

• Conditions: Sinus Pilonidal
• Interventions: Device: Sorbact TM; Device: Algosteril TM

• Registration Number: NCT02011802
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-10
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorbact TM	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.
Algosteril TM	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.

Primary Outcome Measures

Name	Time	Method
Percentage of wounds healed	75 days after surgery

Secondary Outcome Measures

Name	Time	Method
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
antibiotics use	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
number of dressings used	every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

Trial Locations

Locations (4)

Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne; 🇫🇷 Saverne, 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 Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France; 🇫🇷 Strasbourg, France