Feasibility of a Novel Technique for Pilonidal Wound Healing

NCT02330159 | Unknown

• 1 other identifier: ACellCSA01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Pilonidal; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Healthcare costs using the novel protocol

  6 months

• Quality of Life

  6 months

• Disease Recurrence

  6 months

Study Arms (1)

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.

Procedure: Novel Wound Healing Protocol

Interventions

Novel Wound Healing Protocol PROCEDURE

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.

Novel Wound Healing Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.

Sponsors & Collaborators

• Southeast Clinical Research Associates, Houston, Texas: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

Colorectal Surgical Associates

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• Deborah S Keller, MS MD

  Colorectal Surgical Associates

  STUDY DIRECTOR

• Eric M Haas, MD

  Colorectal Surgical Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M Haas, MD

CONTACT

7137900600; ehaasmd@houstoncolon.com

Deborah S Keller, MS MD

CONTACT

7137900600; dkellermd@houstoncolon.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 1, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (1)