Clinical trial NCT01605968: A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
Official title: A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound
Keywords: Obstetrics
Gynecology
Wound healing
Lead sponsor: Bio-medical Carbon Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chung Shan Medical University
First posted: 2012-05-25
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study objective:

The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing.

Study devices:

* Study device: BCT Silver Bandage
* Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing

Study design:

* Randomized, Open-label, interventional, comparative, preventive study with Blinded evaluator.
* All subjects must meet all the inclusion \& exclusion criteria to enter this study in pre-operative phase.
* Eligible subjects will be enrolled after a scheduled operative procedure.
* There is SEVEN visits in this study (one screening eligibility phase up to 7 days before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.
* During each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit V6 for wound evaluation by blinded PI.

Number of subjects: It is expected to recruit ≧150 eligible subjects.

Study Duration: About eighteen month.


Eligibility criteria: Inclusion Criteria:

* Male/Female of any race aged between 18 - 70 years old
* The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen.
* The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week

Exclusion Criteria:

* Patients with known allergy or topical hypersensitivity to ionic silver or alginate
* Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial
* Patients undergoing MRI (Magnetic Resonance Imaging) examination.
* Subject residence is outside the study center city
* Patients was participating in another clinical trial less than 30 days before participation in this trial

Primary outcomes:
measure: Efficacy measurements
timeFrame: 42 days after operation
Secondary outcomes:
measure: Safety Measurement
timeFrame: 42 days after operation
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
Study officials:
affiliation: Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
name: Chih-Jen Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References: