Pilonidal Disease Wound Healing Study

Pilonidal Disease Clinical Trial

Official title: A Prospective Randomized Open-Label Study Examining the Efficacy of Drawtex® Hydroconductive Wound Dressing and Negative Pressure Wound Therapy in Pilonidal Cystectomy Wounds Healing by Secondary Intention - A Pilot Study

Status Recruiting

Clinical Trial Summary

The purpose of the study is to learn about the best way to treat pilonidal cyst wounds and learn which type of bandage (or dressing) can help the wound heal faster after having surgery.

Clinical Trial Description

This pilot study is a prospective randomized open-label study examining the efficacy of Drawtex® Hydroconductive wound dressing and negative pressure wound therapy(NPWT) in pilonidal cystectomy wound healing by secondary intention.

Pilonidal disease has a significant impact on the active duty demographic and the treatments for this disease result in a substantial cost to the military in both duty days lost and for the medical care provided. This study examines Negative Pressure Wound Therapy (NPWT) and the Drawtex® Hydroconductive Dressing for the treatment of surgical wounds resulting from limited excision of pilonidal disease. This clinical trial is a prospective, randomized open label examination of two standard wound therapy modalities with the goal of determining which treatment promotes the most rapid wound healing by secondary intention. Secondary goals include determining which treatment is most cost effective and is most acceptable to patients.

Active duty, retired, and dependent adults (age 18-60 years) who are scheduled to undergo limited surgical cyst excision will be recruited from patients who are referred to the General Surgery Department at Walter Reed National Military Medical Center (WRNMMC). Health care providers in the General Surgery Department will be informed about the study and requested to refer appropriate patients to the study Investigators for evaluation and potential inclusion in the study. The informed consent process will occur at WRNMMC, General Surgery Clinic during the pre-operative clinic visit(s). If the patient consents to screening for inclusion in the study, then they will be assigned a subject number and randomly assigned to a study arm, either NPWT or Drawtex®, preoperatively. The subject will then undergo a limited excision of the pilonidal cyst. If the resulting wound post-surgery meets enrollment criteria, then the subject will be enrolled in the study. At this point, the randomization arm will be revealed either NPWT or Drawtex® dressing. Wound care will be done at the wound care clinic two times a week (biweekly) for approximately 4 weeks or until there is 75% epithelialization, and then on a weekly and then on a monthly basis until 100% epithelialization of the wound or 270 days of follow up are reached. Wound healing progress will be evaluated objectively using a digital planimetry analysis system and blinded evaluators. Secondary objectives include adverse events, bacterial load, expression of inflammatory markers, cost to military and patient satisfaction assessments, ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Disease

• NCT number: NCT01857128
• Study type: Interventional
• Source: Walter Reed National Military Medical Center
• Contact: Michael P McNally, M.D.
• Phone: 301-295-4442
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2013