Clinical trial · Observational
A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
NCT01081522CI-TRIAL-00003237completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.
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 |
|---|---|---|---|
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects over 18 years, willing and able to provide written informed consent. * Subjects who have an excised pilonidal sinus wound left to heal by secondary intent. * Subjects who are willing to commit to having two biopsies being taken during the study. Exclusion Criteria: * Subjects with a history of skin sensitivity to any of the components of the study product * Subjects whose wound is infected * Subjects who have participated in a previous clinical study within the past 3 months * Subjects' with a known history of poor compliance with medical treatments * Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided) * Necrotic/sloughy wounds unless surgically debrided prior to enrolment * Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator * Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study * Subjects with impaired renal function
References
Publications (0)
Data not yet available
No reference posted for this study.