Clinical trial NCT02330159: Feasibility of a Novel Technique for Pilonidal Wound Healing
Official title: A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pilonidal Disease
Pilonidal Cyst
Pilonidal Sinus
Keywords: Pilonidal
Quality of Life
Lead sponsor: Southeast Clinical Research Associates, Houston, Texas
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2015-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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:

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

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Healing
timeFrame: 6 months
Secondary outcomes:
measure: Healthcare costs using the novel protocol
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Disease Recurrence
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Colorectal Surgical Associates
state: Texas
Study officials:
affiliation: Colorectal Surgical Associates
name: Deborah S Keller, MS MD
role: STUDY_DIRECTOR
affiliation: Colorectal Surgical Associates
name: Eric M Haas, MD
role: PRINCIPAL_INVESTIGATOR
References: