Pilonidal Disease Wound Healing Study

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.
• •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.