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

Primary Purpose

Sinus Pilonidal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Algosteril TM
Sorbact TM
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Pilonidal focused on measuring Sorbact TM, Alginates, Dressing, Wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
  • Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
  • Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
  • Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Algosteril TM

Sorbact TM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of wounds healed

Secondary Outcome Measures

Total surface area measure of non-healed wounds
VAS pain
analgesic use
antibiotics use
number of dressings used

Full Information

First Posted
October 10, 2013
Last Updated
November 7, 2017
Sponsor
University Hospital, Strasbourg, France
Collaborators
INRESA Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02011802
Brief Title
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
Acronym
SORKYSA
Official Title
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
INRESA Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Pilonidal
Keywords
Sorbact TM, Alginates, Dressing, Wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Algosteril TM
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sorbact TM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Algosteril TM
Intervention Type
Device
Intervention Name(s)
Sorbact TM
Primary Outcome Measure Information:
Title
Percentage of wounds healed
Time Frame
75 days after surgery
Secondary Outcome Measure Information:
Title
Total surface area measure of non-healed wounds
Time Frame
75 days after surgery
Title
VAS pain
Time Frame
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
Title
analgesic use
Time Frame
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
Title
antibiotics use
Time Frame
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first
Title
number of dressings used
Time Frame
every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne
City
Saverne
ZIP/Postal Code
67700
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32020765
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.
Results Reference
derived

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

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