Pilonidal DiseaseNCT02330159
Feasibility of a Novel Technique for Pilonidal Wound Healing
An observational study of Pilonidal Disease and Pilonidal Cyst, run by Southeast Clinical Research Associates, Houston, Texas at 1 site in United States.
Trial summary
Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life and productivity. Thus, wound healing would have a significant effect on patient quality outcomes, patient quality of life, and healthcare utilization, as well as societal benefits from allowing this vital population to return… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pilonidal Disease, Pilonidal Cyst, Pilonidal Sinus
- What is being tested?
- Novel Wound Healing Protocol
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is patients with Pilonidal Disease undergoing surgical management. Patients will be recruited, evaluated in clinic preoperatively to assure they meet eligibility, then managed via a standard of care surgical procedure, with our protocol used for post-operative wound healing
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Colorectal Surgical Associates
Houston, Texas, 77054
Deborah S Keller, MS MD, 713-790-0600, dkellermd@houstoncolon.com
Eric M Haas, MD, 7137900600, ehaasmd@houstoncolon.com
About this study
Official title: A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes
Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life and productivity. Thus, wound healing would have a significant effect on patient quality outcomes, patient quality of life, and healthcare utilization, as well as societal benefits from allowing this vital population to return to productivity. There is no consensus on postoperative wound care after surgery for PD. Negative pressure therapy is commonly used. However, this therapy is costly and cumbersome, and not evidence-based to optimize wound healing or postoperative patient or financial outcomes. The investigators goal is to investigate the impact of MatriStem® Wound Matrix and MicroMatrix® (ACell, Inc., Columbia, MD) on pilonidal wound healing. Secondary goals are to evaluate the impact of MatriStem Wound Matrix and MicroMatrix on postoperative outcomes, quality of life, and healthcare costs after surgical management of pilonidal disease.
Read the 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
- Conditions
- Pilonidal Disease, Pilonidal Cyst, Pilonidal Sinus
- Being tested
- Novel Wound Healing Protocol
- Keywords
- Pilonidal, Quality of Life
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Wound Healing ProtocolProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Novel Wound Healing Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
To evaluate healing at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
Measured: 6 months
Secondary outcomes (3)
Healthcare costs using the novel protocol
Measured: 6 months
Quality of Life
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
Measured: 6 months
Disease Recurrence
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Clinical Research Associates, Houston, Texas
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Sponsor
- Investigators
- Deborah S Keller, MS MD, Study director, Colorectal Surgical AssociatesEric M Haas, MD, Principal investigator, Colorectal Surgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330159
- Sponsor's protocol ID
- ACellCSA01
- Status last verified
- Nov 2015
- First submitted
- 29 Dec 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT02330159
- Acronym / sponsor ID
- ACellCSA01
- Conditions
- Pilonidal Disease, Pilonidal Cyst, Pilonidal Sinus
- Keywords
- Pilonidal, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Southeast Clinical Research Associates, Houston, TexasUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life and productivity. Thus, wound healing would have a significant effect on patient quality outcomes, patient quality of life, and healthcare utilization, as well as societal benefits from allowing this vital population to return to productivity. There is no consensus on postoperative wound care after surgery for PD. Negative pressure therapy is commonly used. However, this therapy is costly and cumbersome, and not evidence-based to optimize wound healing or postoperative patient or financial outcomes. The investigators goal is to investigate the impact of MatriStem® Wound Matrix and MicroMatrix® (ACell, Inc., Columbia, MD) on pilonidal wound healing. Secondary goals are to evaluate the impact of MatriStem Wound Matrix and MicroMatrix on postoperative outcomes, quality of life, and healthcare costs after surgical management of pilonidal disease.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Wound Healing Protocol | – | Procedure: Novel Wound Healing ProtocolSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with Pilonidal Disease undergoing surgical management. Patients will be recruited, evaluated in clinic preoperatively to assure they meet eligibility, then managed via a standard of care surgical procedure, with our protocol used for post-operative wound healing
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Wound Healing ProtocolAll 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. | Procedure or surgery | Novel Wound Healing Protocol |
Primary outcome
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
3 secondary outcomes
Healthcare costs using the novel protocol
Time frame: 6 months
Quality of Life
Time frame: 6 months
Disease Recurrence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah S Keller, MS MD study director
Colorectal Surgical Associates
Eric M Haas, MD principal investigator
Colorectal Surgical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Disease and Pilonidal Cyst, run by Southeast Clinical Research Associates, Houston, Texas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric M Haas, MD (7137900600, ehaasmd@houstoncolon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.