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


N/A
18 Years
N/A
Not Enrolling
Both
Pilonidal Sinus

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Dheerendra Kommala, MD

Investigator Role:

Study Director

Investigator Affiliation:

ConvaTec Inc.

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CW-0510-09-U352

NCT ID:

NCT01081522

Start Date:

October 2009

Completion Date:

February 2010

Related Keywords:

  • Pilonidal Sinus
  • Pilonidal Sinus

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