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Completed

NCT Number: NCT02011802

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

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.

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Key information

Conditions

Sinus Pilonidal Cysts Neoplasms Pilonidal Sinus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté, Colmar, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Algosteril TM

Device

Sorbact TM

Device

Primary outcomes

  1. Percentage of wounds healed

    Time frame: 75 days after surgery

Secondary outcomes

  1. Total surface area measure of non-healed wounds

    Time frame: 75 days after surgery

  2. VAS pain

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

  3. analgesic use

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

  4. antibiotics use

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

  5. number of dressings used

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Collaborators

  • INRESA Pharma

Registry information

Acronym: SORKYSA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2013
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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