Trial record 5 of 7 for:    Open Studies | "Pilonidal Sinus"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Strasbourg, France
Sponsor:
Collaborator:
INRESA Pharma
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02011802
First received: October 10, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Sinus Pilonidal
Device: Algosteril TM
Device: Sorbact TM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Percentage of wounds healed [ Time Frame: 75 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total surface area measure of non-healed wounds [ Time Frame: 75 days after surgery ] [ Designated as safety issue: No ]
  • VAS pain [ Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first ] [ Designated as safety issue: No ]
  • analgesic use [ Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first ] [ Designated as safety issue: No ]
  • antibiotics use [ Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first ] [ Designated as safety issue: No ]
  • number of dressings used [ Time Frame: every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: December 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: Algosteril TM
Experimental: 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.
Device: Sorbact TM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011802

Contacts
Contact: Benoit Romain, MD 0033 88 12 72 37 benoit.romain@chru-strasbourg.fr

Locations
France
Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté Recruiting
Colmar, France, 68024
Contact: Mirema Nicolae, MD       mirema.nicolae@ch-colmar.fr   
Principal Investigator: Mirema Nicolae, MD         
Sub-Investigator: Ion ZECA, MD         
Sub-Investigator: Patrice DAVID, MD         
Service de Chirurgie Digestive-Centre Hospitalier de Haguenau-64 av du Pr Leriche Not yet recruiting
Haguenau, France, 67500
Contact: Paul Bruant, MD       paul.bruant@ch-haguenau.fr   
Principal Investigator: Paul Bruant, MD         
Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec Recruiting
Mulhouse, France, 68100
Contact: Pierre Barsotti, MD       barsottip@ch-mulhouse.fr   
Principal Investigator: Pierre BARSOTTI, MD         
Sub-Investigator: Sebastian DAN, MD         
Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne Recruiting
Saverne, France, 67700
Contact: Mario Di Liberatore, MD       mario.di.liberatore@ch-saverne.fr   
Principal Investigator: Mario DI LIBERATORE, MD         
Sub-Investigator: Georges MIHAESCU, MD         
Sub-Investigator: Rares IONESCU, MD         
Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France Recruiting
Strasbourg, France, 67091
Contact: Benoit Romain, MD    00 33 3 88 12 72 37    benoit.romain@chru-strasbourg.fr   
Principal Investigator: Serge ROHR, MD, PhD         
Sub-Investigator: Cécile BRIGAND, MD, PhD         
Sub-Investigator: Benoît ROMAIN, MD         
Sub-Investigator: CHILINTSEVA Natalia, MD         
Sub-Investigator: Thomas KNEPFLER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
INRESA Pharma
Investigators
Principal Investigator: Benoit Romain, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02011802     History of Changes
Other Study ID Numbers: 5568
Study First Received: October 10, 2013
Last Updated: June 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Strasbourg, France:
Sorbact TM
Alginates
Dressing
Wound healing

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014