Clinical Trial of BCT KoCarbonAg Silver Bandage
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1 Clinical Trial of BCT KoCarbonAg Silver Bandage A Comparative Efficacy and Safety Study between Bio-Medical Carbon Technology Silver Bandage and Aquacel Ag Dressing In Obstetrical and Gynecological Post-Operation Wound Healing Principal Investigator: Chih-Jen Tseng, M.D, Vice President Affiliation: Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital, Taichung, Taiwan Study Duration: 2012/6/1~ 201/10/16 IRB No.: CS11176 ClinicalTrials.gov Identifier: NCT
2 I. Summary of proposal 1. Study objective The objective of this study is to evaluate the clinical efficacy and safety of BCT Silver Bandage in obstetrical and gynecological wound healing with Aquacel Ag dressing as the comparison. 2. Criteria Inclusion criteria 1. Male/Female of any race aged between years old. 2. The subject is having surgery (Casearian/pfannenstiel or Open Laparotomy incision) within 1 week. Exclusion criteria 1. Patients with known allergy or topical hypersensitivity to ionic silver or alginate. 2. 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.. 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 1 st, rd, 5 th, 12 th day and two follow up visit on the 28 th and the 2 nd post-operative day. During each scheduled visit, each subject will have colored picture on wound area after removal of dressing, and on visit 6 for wound evaluation by blinded PI. Study device: BCT Silver Bandage Comparator device: ConvaTec Aquacel Ag Hydrofiber Dressing. Efficacy Measurements Primary: (1) The incidence of postoperative skin reactions (defined as blisters, itching, erythematous change around the surgical wound site) within 5 days after operation. (2) Wound infection rate within 5 days after operation. 1
3 () Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6. Secondary: (1) Skin discoloration around the incision wound and/or wound keloid formation rate at V6. (2) Patient and Observer Scar Assessment Scale (POSAS) on V, V5 and V6 II. Close Report of Clinical Trial 1. Date of Close Report: 201/10/16 2. Study Duration: 2012/6/1~201/10/16. Outcome Analysis (1) Patient Characteristics BCT Silver Bandage Aquace l Ag dressing Patient number (n) 15 2 Average Age ( years-old) Surgery type: cesarean section myomectomy hysterectomy radical hysterectomy cancer debulking surgery benign ovarian cyst surgery
4 (2) Post Operation Follow Up BCT Silver Bandage Aquacel Ag dressing P value POSAS score on Score 11 1 Score post-operation day 12 Score 12 1 Score 12 (Visit 5) Score 17 1 Score 1 1 Score 1 2 Score 15 1 Score 16 1 Average 11.7 Average POSAS score on Score Score post-operation day 2 Score 12 1 Score 12 2 (Visit 7) Score 1 1 Score 1 Score 17 1 Score 1 1 Score 26 1 Score 16 1 Score 17 1 Score 0 1 Average Average SBSES score on Score 5 1 Score post-operation day 2 Score 1 Score (Visit 7) Score 1 Score 2 Average.8 Average.65 Keloid on post-operation day 1 0 >0.5 2 (n) (Visit 7) Pigmentation on post-operation 0 1 >0.5 day 2 (n) (Visit 7)
5 . Case Discussion Case No.1: 9 year-old woman underwent surgery to remove the endometrial border-line tumor. BCT Silver Bandage was applied and changed every 2 days. After discharged on the 5 th day post-op, BCT silver bandage was changed once a week. Day 1. The wound was 16 cm in length Day. Wound was completely closed. Day 29. The newly formed tissue was and showed redness and swelling. The symptom of redness and swelling smooth and no obvious signs of scar had vanished. formation were observed. Case No.2: 9 year-old woman underwent myomectomy. BCT Silver Bandage was applied and changed three days later. After discharged on the th day post-op, BCT silver bandage was changed once a week. Day 1. The wound was 16 cm in length Day11. Wound was closed with ecchymoma Day 5. The newly formed tissue was and showed redness and swelling. around the center region. smooth and no obvious signs of scar formation were observed. Case No.: 6 year-old woman with cervical cancer underwent radical hysterectomy. BCT Silver Bandage was applied and changed every days. After discharged on the 7 th day post-op, BCT silver bandage was changed once a week. Day 1. The wound was 17 cm in length Day11. Off staples. Wound was closed Day 5. The newly formed tissue was after operation. completely. smooth and even.
6 5. Conclusion (1) There were no adverse events in either BCT silver bandage group or Aquacel Ag dressing group within 5 days after operation, indicating the safety of both dressings. (2) No incidence of wound infection in both BCT silver bandage group and Aquacel Ag dressing group within 5 days after operation. () Based on the POSAS evaluation at 12 days after operation, regarding to vascularization, pigmentation, pain, itch, scar color difference, stiffness of the scar, thickness of the scar and scar appearance, BCT silver bandage group and Aquacel Ag dressing group showed similar healing efficacy with score of 11.5 and 11.8, respectively. Lower score indicated better healing outcome. () On 2 days after operation, the SBSES score in BCT silver bandage group and Aquacel Ag dressing group were.8 and.65, respectively. This indicated both group had equal cosmetic effect. (5) On the 2 day after operation, no subject had wound pigmentation in the BCT Silver Bandage Group, whereas one patient in the Aquacel Ag dressing group has wound pigmentation. (6) On the 2 day after operation, there was one subject developed keloid in the BCT Silver Bandage group. No subject in the Aquacel Ag dressing group developed keloid. (7) POSAS score on 2 nd day after operation in BCT Silver Bandage group and Aquacel Ag dressing group were 12.7 and 12.8, respectively, indicating both group had equal cosmetic effect. (8) There were no adverse events in either group during entire applying period, indicating the safety of both dressings. 5
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