Your session is about to expire
← Back to Search
Bandage Comparison for Pilonidal Disease
Phase 4
Waitlist Available
Led By Michael P McNally, M.D.
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-surgical wound measurement (length x width x depth) greater than or equal to 3 cm in length, greater than or equal to 1.5 cm in width, and greater than or equal to 1.5 cm in depth. Rationale: satisfies the minimum size wound that NPWT may be employed
Healthy adult male or non-lactating female age 18 to 60 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 270 days or 9 months
Awards & highlights
Study Summary
This trial is comparing two types of bandages to see which one helps pilonidal cyst wounds heal faster after surgery.
Who is the study for?
Adults aged 18-60 with pilonidal disease needing surgery can join this study. They must score well on a knowledge test about the study, be available for its duration, and consent to participate. Smokers, those with complex pilonidal disease or certain health conditions like autoimmune diseases or diabetes are excluded.Check my eligibility
What is being tested?
The trial is testing two types of dressings: Drawtex dressing and Negative Pressure Wound Therapy (NPWT), to see which one helps wounds heal faster after pilonidal cyst surgery. Participants will be assigned to one of these treatments post-surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort at the wound site, skin irritation from the dressings, and possible infection risks associated with wound care procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgical wound is at least 3 cm long, 1.5 cm wide, and 1.5 cm deep.
Select...
I am a healthy adult between 18 and 60 years old and not breastfeeding.
Select...
I need surgery for a pilonidal cyst that involves removing the cyst and some surrounding area.
Select...
I have chronic pilonidal disease with frequent abscesses or symptoms affecting my daily life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 270 days or 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 270 days or 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to wound healing
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Drawtex Hydroconductive DressingExperimental Treatment1 Intervention
Gauze-like dressing placed onto wound
Group II: Negative Pressure Wound TherapyActive Control1 Intervention
Usual care including vacuum and canister
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Drawtex dressing
2010
N/A
~10
Find a Location
Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
137 Previous Clinical Trials
34,467 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,164 Total Patients Enrolled
Michael P McNally, M.D.Principal InvestigatorDepartment of General Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a pilonidal abscess or infection within the last 6 weeks.I am worried about bleeding or cancer near my wound.I do not have autoimmune diseases like lupus, rheumatoid arthritis, or others that could affect wound healing.I do not have any significant heart, lung, liver, or kidney problems.I have an immune system disorder or am on immune-weakening medication (except for inhaled or topical steroids).I have limited mobility or cannot walk.My surgical wound is at least 3 cm long, 1.5 cm wide, and 1.5 cm deep.I am not pregnant or breastfeeding.I am HIV positive.My surgeon recommends a different treatment for my pilonidal disease.I have been diagnosed with diabetes.I am unwilling or unable to sign the consent form.My wound is large but does not show any bone.I am a healthy adult between 18 and 60 years old and not breastfeeding.I need surgery for a pilonidal cyst that involves removing the cyst and some surrounding area.I have chronic pilonidal disease with frequent abscesses or symptoms affecting my daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Drawtex Hydroconductive Dressing
- Group 2: Negative Pressure Wound Therapy
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the criteria for this clinical trial include individuals under thirty years of age?
"According to the conditions for inclusion, participants must be aged 18 up to 60. Additionally, there are additional studies available for children and elderly individuals over the age of 65."
Answered by AI
Who is eligible to enroll in this medical research program?
"To qualify for this research, individuals must possess a diagnosis of pilonidal disease and be between the ages 18-60. This trial is actively seeking 30 participants."
Answered by AI
Has Drawtex dressing obtained endorsement from the Federal Drug Administration?
"Evaluated to be a 3 on the safety scale, Drawtex dressing has been approved for use in Phase 4 trials."
Answered by AI
Are there currently any open opportunities to participate in this clinical trial?
"The clinicaltrials.gov website states that this medical trial, which was posted on March 1st 2013 and last modified 17th May of the same year, is not actively recruiting patients at present. Nevertheless, 4 other studies are currently in search for participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger