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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT02011802
• Collaborator: INRESA Pharma (Industry)
• Enrollment: 251
• Locations: 4
• Arms: 2
• Actual Duration (Months): 45
• Patients Per Site: 62.8
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sinus Pilonidal	Device: Algosteril TM; Device: Sorbact TM	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 251 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Percentage of wounds healed [75 days after surgery]

Secondary Outcome Measures

1. Total surface area measure of non-healed wounds [75 days after surgery]

2. VAS pain [every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first]

3. analgesic use [every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first]

4. antibiotics use [every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first]

5. number of dressings used [every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté	Colmar		France	68024
2	Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec	Mulhouse		France	68100
3	Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne	Saverne		France	67700
4	Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France	Strasbourg		France	67091

Sponsors and Collaborators

• University Hospital, Strasbourg, France
• INRESA Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02011802
• Other Study ID Numbers: 5568
• First Posted: Dec 13, 2013
• Last Update Posted: Nov 9, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Strasbourg, France: Sorbact TM; Alginates; Dressing; Wound healing
• Additional relevant MeSH terms: Pilonidal Sinus

Study Results

No Results Posted as of Nov 9, 2017