Pilonidal Disease Wound Healing Study

NCT01857128 | Unknown Phase 4

• 1 other identifier: 382094-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

• Time to wound healing

  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.

  Up to 270 days or 9 months

Study Arms (2)

Drawtex Hydroconductive Dressing

EXPERIMENTAL

Gauze-like dressing placed onto wound

Device: Drawtex dressing

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

Usual care including vacuum and canister

Device: Negative Pressure Wound Therapy

Interventions

Drawtex dressing DEVICE

Drawtex Hydroconductive Dressing

Negative Pressure Wound Therapy DEVICE

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Walter Reed National Military Medical Center -Dept of General Surgery

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Michael P McNally, M.D.

  Department of General Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael P McNally, M.D.

CONTACT

301-295-4442

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 20, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

US (1)