NCT01081522

Completed

A Preliminary, Non-comparative Study to Evaluate a Bioresorb...

ConvaTec Inc.Source

Other study identifiers

Sponsor study identifier

CW-0510-09-U352

Study Type

observational

Actual enrollment (reported)

12

Locations

2 countries

Sites

3

Timeline

Study Start

October 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2010

Actual (reported)

Study Completion

February 2010

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 12 participants
Study completion date: February 2010
Actual (reported)
Listed locations: 2 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2010
Actual (reported)
Study Completion
February 2010
Actual (reported)
First Submitted
March 4, 2010
Actual (reported)
First Posted
March 5, 2010
Actual (reported)

Last Updated: March 5, 2010
Status Verified: March 2010
Last Update Submitted: March 4, 2010

Conditions

Pilonidal Sinus

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

secondary care clinics

You may qualify if:

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.

You may not qualify if:

Subjects with a history of skin sensitivity to any of the components of the study product

Sponsors & Collaborators

ConvaTec Inc.
Industrylead

Study Sites (3)

Hillerod Hospital

Hillerød, Dk 3400, Denmark

Wound Healing Research Unit

Heathpark, Cardiff, CF 14 4XN, United Kingdom

Scunthorpe General Hospital

Scunthorpe, North Lincolnshire, DN 15 7BH, United Kingdom

Biospecimen

Retention: SAMPLES WITH DNA

tissue (3mm punch biopsy)

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

Dheerendra Kommala, MD
ConvaTec Inc.
STUDY DIRECTOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

October 2009

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableCompleted

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NCT01513382

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Not ApplicableCompleted

NCT04856605

Umblical Pilonidal Sinus Evaluation

Completed

NCT03271996

Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Not ApplicableTerminated

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 with impaired renal function

Contact the study team to confirm eligibility.

Primary Completion

February 2010

Actual (reported)

Study Completion

February 2010

Actual (reported)

Last Updated

March 5, 2010

Record last verified: 2010-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01081522
Data provider: ClinicalTrials.gov
Source updated: 2010-03-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:55 UTC

Locations

DK(1)GB(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations