Incidence of Surgical Site Infection with or without Postoperative Antibiotics in Dermatologic Surgery (SSI-PADS): an open-label, randomized, parallel-group study

JRCT ID: jRCT1031220718

Registered date:21/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Skin disease
• Date of first enrollment: 21/03/2023
• Target sample size: 700
• Study type: Interventional

Intervention(s)

Randomly assign to the following two groups
(Cefaclor non-administered group)
Apply white petrolatum to the wound once or twice a day from the day of surgery until 7 days after surgery. If there is pain in the wound, take acetaminophen or loxoprofen orally as needed.

(Cefaclor administration group)
Cefaclor 250 mg is taken orally after each meal three times a day from after dinner on the day of surgery until noon three days after surgery. In addition, apply white petrolatum to the wound once or twice a day from the day of surgery until 7 days after surgery. If there is pain in the wound, take acetaminophen or loxoprofen orally as needed.

Outcome(s)

• Primary Outcome: Incidence of SSI at 7 days after surgery

Secondary Outcome

1. Incidence of SSI at 1 month after surgery
2. Incidence of wound dehiscence, postoperative hemorrhage, and grade 3 or higher non-hematologic adverse events at 7 days and 1 month after surgery
3. Scar condition at 7 days and 1 month after surgery (Scar width (cm), POSAS (The Patient and Observer Scar Assessment Scale), Vancouver Scar Scale)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Those with benign or malignant lesions of the skin or subcutaneous adipose tissue of the head and neck, trunk, extremities, or limbs.
2. Those with a lesion whose incision line is considered to be less than 6 cm.
3. Those who undergo surgery under local anesthesia and whose reconstructive procedure is either post excisional open treatment or suture with the intention of scar healing.
4. Age: 18 years of age or older at the time consent is obtained.
5. Male or female.
6. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study.
7. Those who can make outpatient visits in accordance with the research implementation schedule.

Exclude criteria

1. Those who have taken topical, oral, or intravenous antibiotics to the planned surgical site within 48 hours prior to the surgery.
2. Those subjects whose lesions to be resected are infected wounds; those who perform skin grafting and skin flap creation; those who have lesions scheduled for resection in the mucous membranes such as the oral cavity or the genital area.
3. Those who are allergic to antiseptics, beta-lactam antibiotics, petroleum jelly, acetaminophen, loxoprofen.
4. Those with prosthetic valve, history of endocarditis, congenital heart disease, heart transplantation, valvular repair* within the past 6 months after.
*Exclude mitral valve prolapse, rheumatic heart disease, bicuspid valve disease, and calcified aortic stenosis.
5. Those undergoing surgery that requires placement of a drain.
6. Those with infectious diseases requiring systemic treatment.
7. Those with a fever of 38.0 degrees Celsius or higher at the time of registration.
8. Those within 2 years of artificial joint surgery.
9. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
10. Those on immunosuppressive drugs after solid organ or bone marrow transplantation, tthose with congenital immunodeficiency syndrome, and AIDS patients.
11. Those who cannot take capsules orally (e.g., during tube feeding or central intravenous nutrition).
12. Those with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
13. Those with poorly controlled diabetes mellitus (mean HbA1c 8.5 or higher for 3 months before surgery) or hypertension (not excluded if controlled with medication).
14. Those with unstable angina (angina with onset or worsening attacks within the last 3 weeks) or a history of myocardial infarction within 6 months.
15. Those with a major predisposition to bleeding (not considered a predisposition to bleeding in the following cases: taking antiplatelet agents, taking warfarin with INR<3, or using other anticoagulants).
16. Others who are judged inappropriate for participation in this study by the investigator or co-investigator.

Related Information

• Primary Sponsor: Yoshizaki Ayumi