Clinical trial · Observational
Feasibility of a Novel Technique for Pilonidal Wound Healing
A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Cyst | — | UNRESOLVED | — |
| Pilonidal Disease | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel Wound Healing Protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Novel Wound Healing Protocol
- description
- 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.
- interventionNames
- Procedure: Novel Wound Healing Protocol
Primary outcomes (1)
- measure
- Wound Healing
- timeFrame
- 6 months
- description
- To evaluate healing at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort
Secondary outcomes (3)
- measure
- Healthcare costs using the novel protocol
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available