NCT02011802: SORKYSA

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

Completed NA Last updated 16 January 2026

What this trial tests

NA trial testing Algosteril TM in Sinus Pilonidal in 251 participants. Completed in 1 September 2017.

Timeline

1 December 2013

Primary endpoint
1 September 2017

1 September 2017

Quick facts

Lead sponsor	University Hospital, Strasbourg, France
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	251
Start date	1 December 2013
Primary completion	1 September 2017
Estimated completion	1 September 2017
Sites	4 locations across France

Drugs / interventions tested

• Algosteril TM
• Sorbact TM

Conditions studied

• Sinus Pilonidal — all drugs for Sinus Pilonidal →

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Sinus Pilonidal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of wounds healed
  Time frame: 75 days after surgery

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Borrowing the Features of Biopolymers for Emerging Wound Healing Dressings: A Review.
   Gardikiotis I, Cojocaru FD, Mihai CT, Balan V, et al · · 2022 · cited 33× · PMID 35955912 · DOI 10.3390/ijms23158778
2. Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study).
   Romain B, Mielcarek M, Delhorme JB, Meyer N, et al · · 2020 · cited 7× · PMID 32020765 · DOI 10.1002/bjs5.50259