Uncomplicated Cutaneous Abscess Clinical Trial
Official title:
A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
| NCT number | NCT01698996 |
| Other study ID # | 102928 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | October 1, 2012 |
| Last updated | March 30, 2015 |
| Start date | March 2013 |
| Verified date | March 2015 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - = 18 years - Abscess = 5cm in diameter - Truncal or extremity location Exclusion Criteria: - Post-operative abscess (abscess in location of operative incision, operation within the last 4 months) - HIV/immunocompromised/transplant recipient/chronic oral steroid use - Fever at triage (temp =38 degrees Celsius) - Abscess secondary to Crohn's - Multiple abscesses requiring drainage - Prior participation in the study for the same abscess - Incision and drainage performed with no packing required, or where abscess cavity is <1 cm max diameter - Bartholins/perigenital, perianal, or facial abscesses - Complicated abscesses (fistula, suspicion of muscular extension, consultation/direct referral to general surgery) - Inability to give consent |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | London Health Sciences Centre | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Proportion of wounds "closed" at 2 weeks (wound size <0.5 cm length and depth and no drainage) | 14 days | Yes | |
| Other | Pain scores (daily pain scores for first week from patient diary) | 7 days | No | |
| Other | Amount of Pain Medication Used | 7 days | No | |
| Other | Resources Utilized | 14 days | No | |
| Primary | Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics) | 7 days | Yes | |
| Secondary | Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage) | 7 days | Yes |