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