Clinical trial · Interventional
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sinus Pilonidal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Algosteril TM | Device | — | UNRESOLVED |
| Sorbact TM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Algosteril TM
- 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.
- interventionNames
- Device: Algosteril TM
- type
- EXPERIMENTAL
- label
- Sorbact TM
- 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.
- interventionNames
- Device: Sorbact TM
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTRomain 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