Status:
UNKNOWN
Pilonidal Disease Wound Healing Study
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Pilonidal Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- Healthy adult male or non-lactating female age 18 to 60 years inclusive.
- Diagnosis of pilonidal disease with cyst requiring surgery, with undermining to remove the cyst and requiring limited excision with healing by secondary intension.
- 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.
- Military active duty members need a supervisor signed memorandum to participate (Active Duty Supervisor's Approval Memo).
- Understands the purpose and risks of study by scoring 80% or higher on knowledge assessment test.
- Available and willing to participate for the duration of the study (approximately 30-270 days maximum depending on time to wound healing).
- Available and willing to provide written informed consent.
- Able and willing to follow instructions as per protocol.
- Available for all visits as per protocol. Post Surgery Study Enrollment Criteria
- 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
- Does not meet all inclusion criteria.
- 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.
- Known HIV infection.
- Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed).
- 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.
- 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.
- Known documented history of diabetes mellitus.
- Non-ambulatory or limited mobility. Rationale: non ambulatory patients may have altered wound healing in the sacral area due to constant pressure from positioning.
- 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.
- Complex pilonidal disease determined by the surgeon to require a procedure other than the study procedure for appropriate treatment of the disease.
- Acute pilonidal abscess or infection within 6 weeks of planned operative date.
- Concerns for arterial bleeding or cancer in the wound bed or in the vicinity of the dressing.
- 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.
- Lack of or unwillingness to provide/sign informed consent. Post Surgery Exclusion Study Criteria
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01857128
Start Date
March 1 2013
Last Update
May 20 2013
Active Locations (1)
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1
Walter Reed National Military Medical Center -Dept of General Surgery
Bethesda, Maryland, United States, 20889