Feasibility of a Novel Technique for Pilonidal Wound Healing

Status unconfirmed

Conditions studied: Pilonidal Disease, Pilonidal Cyst, Pilonidal Sinus

In brief

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.

Key facts

Study ID

NCT02330159

Run by

Southeast Clinical Research Associates, Houston, Texas

People needed

20

Starts

2015-02-01

Expected to finish

2016-07-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Colorectal Surgical Associates — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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