Feasibility of a Novel Technique for Pilonidal Wound Healing

Pilonidal Sinus Clinical Trial

Official title:

A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02330159
• Other study ID #: ACellCSA01
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2014
• Last updated: November 17, 2015
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: Southeast Clinical Research Associates, Houston, Texas
• Contact: Eric M Haas, MD
• Phone: 7137900600
• Email: ehaasmd[@]houstoncolon.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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 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.

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pilonidal Cyst
• Pilonidal Disease
• Pilonidal Sinus

Intervention

Procedure:
• Novel Wound Healing Protocol
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.

Locations

Country	Name	City	State
United States	Colorectal Surgical Associates	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southeast Clinical Research Associates, Houston, Texas	ACell Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No
Secondary	Healthcare costs using the novel protocol		6 months	No
Secondary	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	6 months	No
Secondary	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	6 months	No