Feasibility of a Novel Technique for Pilonidal Wound Healing
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | July 2016 |
| Contact: | Eric M Haas, MD |
| Email: | ehaasmd@houstoncolon.com |
| Phone: | 7137900600 |
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.
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.
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:
1. Wound healing at 6 months. Success is defined at a 60% healing rate of
epithelialization and wound contracture by volume measurements in centimeters.
2. Observation of quality of life, total costs for treatment, recurrence and reoperation
rates at 6 months
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:
1. Wound healing at 6 months. Success is defined at a 60% healing rate of
epithelialization and wound contracture by volume measurements in centimeters.
2. Observation of quality of life, total costs for treatment, recurrence and reoperation
rates at 6 months
Inclusion Criteria:
1. Subjects who have pilonidal disease that are being scheduled for surgical excision
2. Subjects who are 18 years of age and older
3. Subjects of either gender
4. Subjects with no previous drainage or surgical procedures for pilonidal disease
5. 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:
1. Subjects with previous drainage or surgical procedures for pilonidal disease.
2. Subjects who are pregnant.
3. Subjects with an allergy or medical condition that may interfere with the use of the
study medications.
4. Subjects who have another condition or general disability or infirmity that in the
opinion of the investigator precludes further participation in the study.
5. Patients under 16 years of age
6. Patients with incomplete medical records
7. Patients on chronic opioids for pain management.
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