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Pilonidal Disease Wound Healing Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857128
Recruitment Status : Unknown
Verified May 2013 by Michael P. McNally, Walter Reed National Military Medical Center.
Recruitment status was:  Recruiting
First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Michael P. McNally, Walter Reed National Military Medical Center

Tracking Information
First Submitted Date  ICMJE May 7, 2013
First Posted Date  ICMJE May 20, 2013
Last Update Posted Date May 20, 2013
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
Time to wound healing [ Time Frame: Up to 270 days or 9 months ]
Time (days) to 100% epithelialization of the wound bed will be evaluated using digitized planimetry in a random manner by two independent evaluators blinded to the study treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilonidal Disease Wound Healing Study
Official Title  ICMJE 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
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pilonidal Disease
Intervention  ICMJE
  • Device: Drawtex dressing
  • Device: Negative Pressure Wound Therapy
Study Arms  ICMJE
  • Experimental: Drawtex Hydroconductive Dressing
    Gauze-like dressing placed onto wound
    Intervention: Device: Drawtex dressing
  • Active Comparator: Negative Pressure Wound Therapy
    Usual care including vacuum and canister
    Intervention: Device: Negative Pressure Wound Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 17, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857128
Other Study ID Numbers  ICMJE 382094-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Michael P. McNally, Walter Reed National Military Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Walter Reed National Military Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Michael P McNally, M.D. Department of General Surgery
PRS Account Walter Reed National Military Medical Center
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP