- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330159
Feasibility of a Novel Technique for Pilonidal Wound Healing
A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators study has 2 main goals:
Aim 1: To evaluate wound healing at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
Aim 2: To evaluate pilonidal recurrence, reoperation rates, healthcare utilization, and quality of life at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
The investigators main hypothesis is that using MatriStem Wound Matrix and MicroMatrix for postoperative wound care will significantly improve healing rates, healthcare utilization, and quality of life outcomes. The null hypothesis of the study is that there is no significant difference in healing rates, healthcare utilization, and quality of life outcomes between MatriStem Wound Matrix/ MicroMatrix and negative pressure dressing cohorts. The alternative hypothesis is that there are differences in healing rates, healthcare utilization, and quality of life outcomes between MatriStem Wound Matrix/ MicroMatrix and negative pressure dressing cohorts.
Twenty consecutive patients undergoing surgical excision for Pilonidal Disease will be recruited for treatment. All patients will undergo comparable surgical excision and application of the novel protocol. The wound will be left undisturbed for 10-14 days (until the 1st follow-up visit). At the 1st scheduled postoperative visit, the wound will reassessed in the operative suite, and a second application of the protocol may be performed at the surgeon's discretion. The next follow-up visits will be at 1 month, 3 months, and 6 months. At these visits, the wound bed will be measured, photo documentation will be captured, and patients will complete a survey to assess quality of life.
Study Endpoints are:
- Wound healing at 6 months. Success is defined at a 60% healing rate of epithelialization and wound contracture by volume measurements in centimeters.
- Observation of quality of life, total costs for treatment, recurrence and reoperation rates at 6 months
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eric M Haas, MD
- Phone Number: 7137900600
- Email: ehaasmd@houstoncolon.com
Study Contact Backup
- Name: Deborah S Keller, MS MD
- Phone Number: 7137900600
- Email: dkellermd@houstoncolon.com
Study Locations
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-
Texas
-
Houston, Texas, United States, 77054
- Recruiting
- Colorectal Surgical Associates
-
Contact:
- Eric M Haas, MD
- Phone Number: 7137900600
- Email: ehaasmd@houstoncolon.com
-
Contact:
- Deborah S Keller, MS MD
- Phone Number: 713-790-0600
- Email: dkellermd@houstoncolon.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects who have pilonidal disease that are being scheduled for surgical excision
- Subjects who are 18 years of age and older
- Subjects of either gender
- Subjects with no previous drainage or surgical procedures for pilonidal disease
- Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.
Exclusion Criteria:
- Subjects with previous drainage or surgical procedures for pilonidal disease.
- Subjects who are pregnant.
- Subjects with an allergy or medical condition that may interfere with the use of the study medications.
- Subjects who have another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
- Patients under 16 years of age
- Patients with incomplete medical records
- Patients on chronic opioids for pain management.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Novel Wound Healing Protocol
Subjects who have pilonidal disease that are being scheduled for surgical excision with our novel wound healing protocol.
The disease can be actively infected or chronic.
|
All patients will undergo surgical excision of the pilonidal disease and application of the novel wound healing protocol.
After excision, MatriStem MicroMatrix powder will be applied to the wound bed.
A MatriStem Multilayer Wound Matrix sheet will then be placed over the MatriStem MicroMatrix, secured in place, then covered with surface dressings.
The wound should be left undisturbed for 10-14 days (until the 1st follow-up visit).
At the 1st postoperative visit, the wound will reassessed, and a second application of the MicroMatrix to the wound bed may be performed.
At subsequent follow-up visits at 1, 3, and 6 months, the wound bed will be measured, photo documentation will be captured, and patients will complete a survey to assess quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Healing
Time Frame: 6 months
|
To evaluate healing at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare costs using the novel protocol
Time Frame: 6 months
|
6 months
|
|
Quality of Life
Time Frame: 6 months
|
To evaluate quality of life at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
|
6 months
|
Disease Recurrence
Time Frame: 6 months
|
To evaluate recurrence and reoperation rates at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Deborah S Keller, MS MD, Colorectal Surgical Associates
- Principal Investigator: Eric M Haas, MD, Colorectal Surgical Associates
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACellCSA01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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