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OpenTrials
Completed

NCT Number: NCT01081522

A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hillerod Hospital, Hillerød, Dk 3400, Denmark

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Who can participate

Healthy volunteers accepted: No

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

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

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 5, 2010
Registry last updated
Mar 5, 2010

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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