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Feasibility of a Novel Technique for Pilonidal Wound Healing

NCT02330159 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2015-11-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • Southeast Clinical Research Associates, Houston, Texas

    lead OTHER

Principal Investigators

  • Deborah S Keller, MS MD · Colorectal Surgical Associates

  • Eric M Haas, MD · Colorectal Surgical Associates

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330159 on ClinicalTrials.gov