Pilonidal Disease Wound Healing Study

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,

Inclusion Criteria:

1. Healthy adult male or non-lactating female age 18 to 60 years inclusive.

2. Diagnosis of pilonidal disease with cyst requiring surgery, with undermining to
remove the cyst and requiring limited excision with healing by secondary intension.

3. Presence of chronic symptomatic pilonidal disease defined as at least one pilonidal
sinus and a history of at least two acute pilonidal abscesses or persistent symptoms
altering patient's quality of life.

4. Military active duty members need a supervisor signed memorandum to participate
(Active Duty Supervisor's Approval Memo).

5. Understands the purpose and risks of study by scoring 80% or higher on knowledge
assessment test.

6. Available and willing to participate for the duration of the study (approximately
30-270 days maximum depending on time to wound healing).

7. Available and willing to provide written informed consent.

8. Able and willing to follow instructions as per protocol.

9. Available for all visits as per protocol. Post Surgery Study Enrollment Criteria

10. Post-surgical wound measurement (length x width x depth):

(cm x 1.5 cm x 1.5 cm)greater than or equal to 3 cm in length, greater than or equal to
1.5 cm in width, and greater than or equal to1.5 cm in depth.

Rationale: satisfies the minimum size wound that NPWT may be employed.

Exclusion Criteria:

1. Does not meet all inclusion criteria.

2. Pregnant (by history or as ascertained by pregnancy test) or lactating female
Rationale: immune modulation and potential for altered healing trajectory as well as
operative risk to fetus for elective procedure.

3. Known HIV infection.

4. Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and
topical steroids are allowed).

5. Autoimmune disease (clinical, preexisting anti-dsDNA antibodies 30 IU, or positive
ANA ELISA with a titer greater than 1:80 on pre-operative screening) Exclusionary
medical histories will include the following diagnoses: systemic lupus erythematosus,
rheumatoid arthritis, mixed connective tissue disease, progressive systemic
sclerosis, Sjogren's syndrome, polymyositis/ dermatomyositis, and vasculitis
Rationale: potential for altered wound healing.

6. Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal
abnormality, as determined by physical examination or basic laboratory screening
performed at pre-operative evaluation.

7. Known documented history of diabetes mellitus.

8. Non-ambulatory or limited mobility. Rationale: non ambulatory patients may have
altered wound healing in the sacral area due to constant pressure from positioning.

9. History of current tobacco use: defined as cigarette smoking greater than or equal to
one half pack (10 cigarettes) per day:

Rationale: confounding factor prolonging wound healing.

10. Complex pilonidal disease determined by the surgeon to require a procedure other than
the study procedure for appropriate treatment of the disease.

11. Acute pilonidal abscess or infection within 6 weeks of planned operative date.

12. Concerns for arterial bleeding or cancer in the wound bed or in the vicinity of the
dressing.

13. Any other significant finding which, in the opinion of the investigator, would
increase the subject's risk of having an adverse outcome from participating in this
protocol.

14. Lack of or unwillingness to provide/sign informed consent. Post Surgery Exclusion
Study Criteria

15. Post-surgical wound measurement restrictions (enth x width x depth):

(0 cm x 10 cm x 6 cm)greater than or equal to 10 cm in length, greater than or equal to 10
cm in width OR greater than or equal to 6 cm in depth. If bone is visible or exposed, the
subject must be excluded.

Rationale: large wounds are deemed complex and wounds with exposed or visible bone require
antibiotic therapy.