Pilonidal DiseasePhase 4NCT01857128
Pilonidal Disease Wound Healing Study
A Phase 4 study testing Drawtex dressing and Negative Pressure Wound Therapy in people with Pilonidal Disease, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Drawtex dressing and Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Michael P McNally, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Walter Reed National Military Medical Center -Dept of General Surgery
Bethesda, Maryland, 20889
Michael P McNally, M.D., 301-295-4442, michael.p.mcnally.mil@health.mil
John S Maddox, M.D., 301-295-4440, john.s.maddox.mil@health.mil
About this study
Official title: 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
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.
Read the 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,
- Conditions
- Pilonidal Disease
- Being tested
- Drawtex dressing, Negative Pressure Wound Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawtex dressingDevice
Negative Pressure Wound TherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Drawtex Hydroconductive Dressing | Experimental | Gauze-like dressing placed onto wound Receives: Device: Drawtex dressing |
| Negative Pressure Wound Therapy | Active comparator | Usual care including vacuum and canister Receives: Device: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 270 days or 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Michael P. McNally, Walter Reed National Military Medical Center
- Investigators
- Michael P McNally, M.D., Principal investigator, Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857128
- Sponsor's protocol ID
- 382094-2
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01857128
- Acronym / sponsor ID
- 382094-2
- Conditions
- Pilonidal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drawtex Hydroconductive Dressing | Experimental | Device: Drawtex dressingGauze-like dressing placed onto wound |
| Negative Pressure Wound Therapy | Active comparator | Device: Negative Pressure Wound TherapyUsual care including vacuum and canister |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drawtex dressing | Device | Drawtex Hydroconductive Dressing |
| Negative Pressure Wound Therapy | Device | Negative Pressure Wound Therapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P McNally, M.D. contact
Michael P McNally, M.D. principal investigator
Department of General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drawtex dressing and Negative Pressure Wound Therapy in people with Pilonidal Disease, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael P McNally, M.D. (301-295-4442), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wound healing (time frame: Up to 270 days or 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.