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

NCT02011802 | Completed

• 1 other identifier: 5568
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 4

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.

Conditions

Sinus Pilonidal

Keywords

Sorbact TM; Alginates; Dressing; Wound healing

Outcome Measures

Primary Outcomes (1)

• Percentage of wounds healed

  75 days after surgery

Secondary Outcomes (5)

• 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

• analgesic use

  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

• number of dressings used

  every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first

Study Arms (2)

Algosteril TM

ACTIVE COMPARATOR

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

Sorbact TM

EXPERIMENTAL

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

Interventions

Algosteril TM DEVICE

Algosteril TM

Sorbact TM DEVICE

Sorbact TM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients participating in another clinical trial
• Known for intolerance to one of the dressings
• Known pregnancy
• Uncontrolled diabetes (fasting glucose \>2g/l)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• INRESA Pharma: collaborator

Study Sites (4)

Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté

Colmar, 68024, France

Location

Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec

Mulhouse, 68100, France

Location

Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne

Saverne, 67700, France

Location

Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 32020765 RESULT

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)