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Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula. A randomized, double-blind clinical trial
EU CTIS ID: 2024-520193-35-00
What this study is testing
To determine the efficacy of antibiotic therapy after surgical drainage of the perianal abscess in the development of perianal fistula.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female adult patients of at least 18 years of age.
- First episode of perianal abscess.
- Oral feeding.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Signed written informed consent in accordance with ICH/GCP and local legislation, obtained prior to any study procedure.
You likely can't join if
- Allergy or intolerance to amoxicillin/clavulanic acid.
- Contraindication to the performance of any of the study procedures.
- History of previous perianal surgery.
- Any clinical condition, and/or analytical alteration that, in the opinion of the investigator, is considered clinically significant enough to participate in the study. The following are considered as such: a) Previous perianal fistula or fistula diagnosed during surgery. b) Complex abscess. c) Marked cellulitis after surgical drainage. d) History of inflammatory bowel disease. e) History of anal cancer. f) Previous trauma or radiotherapy. g) Diabetes mellitus. h) Immunosuppressed: oncology patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease. i) Prosthetic valves. j) Morbid obesity (BMI>40). k) Signs of severe sepsis
- Women with positive pregnancy test result or breast-feeding.
- Unwillingness or inability to follow the procedures described in the protocol.
See the full eligibility criteria
- Male or female adult patients of at least 18 years of age.
- First episode of perianal abscess.
- Oral feeding.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Signed written informed consent in accordance with ICH/GCP and local legislation, obtained prior to any study procedure.
- Allergy or intolerance to amoxicillin/clavulanic acid.
- Contraindication to the performance of any of the study procedures.
- History of previous perianal surgery.
- Any clinical condition, and/or analytical alteration that, in the opinion of the investigator, is considered clinically significant enough to participate in the study. The following are considered as such: a) Previous perianal fistula or fistula diagnosed during surgery. b) Complex abscess. c) Marked cellulitis after surgical drainage. d) History of inflammatory bowel disease. e) History of anal cancer. f) Previous trauma or radiotherapy. g) Diabetes mellitus. h) Immunosuppressed: oncology patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease. i) Prosthetic valves. j) Morbid obesity (BMI>40). k) Signs of severe sepsis
- Women with positive pregnancy test result or breast-feeding.
- Unwillingness or inability to follow the procedures described in the protocol.
- Inability to give written informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.