Recruiting

Pilonidal Healing

Sponsor:

Southeast Clinical Research Associates, Houston, Texas

Code:

NCT02330159

Conditions

Pilonidal Disease

Pilonidal Cyst

Pilonidal Sinus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Novel Wound Healing Protocol

Study Details

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.

Conditions

Pilonidal Disease

Pilonidal Cyst

Pilonidal Sinus

Study ID

NCT02330159

Start date

Feb, 2015

Status verified date

Nov, 2015

Completion date

Jul, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Wound Healing [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Eric M Haas, MD

7137900600ehaasmd@houstoncolon.com

Deborah S Keller, MS MD

7137900600dkellermd@houstoncolon.com

Locations

Colorectal Surgical Associates

Recruiting

Houston, Texas, United States, 77054

Contacts

Deborah S Keller, MS MD

713-790-0600dkellermd@houstoncolon.com

Eric M Haas, MD

7137900600ehaasmd@houstoncolon.com

More Information

Sponsor

Southeast Clinical Research Associates, Houston, Texas

Last update posted

Nov 20, 2015

Last verified

Nov, 2015

Keywords

  • Pilonidal
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southeast Clinical Research Associates, Houston, Texas on 2015-11-20.