To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
NCT Number: NCT06558240
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cesarean Section|Surgical Wound|Surgical Wound Infection|Wounds and Injuries
Interventions: DEVICE: HERADERM Hydrogel Wound Dressing (Sterile)
Sponsor: Taipei Veterans General Hospital, Taiwan
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-07
Locations: Taipei Veterans General Hospital, Taipei City, Taiwan

Summary:
The wound of cesarean section involves multiple layers of tissue and often cause significant postoperative pain. The epidermal wound typically heals within 1 to 2 weeks after surgery. In current clinical practice, advanced wound dressings are commonly used for postoperative wound care. The theory of moist wound healing was first proposed by Winter in 1962, advocating that maintaining a moist environment around the wound can accelerate the healing process.

HERADERM Hydrogel Wound Dressing (Sterile) was approved by the Taiwan FDA in 1999. Although HERADERM Hydrogel Wound Dressing (Sterile) are frequently used clinically for post-cesarean section wound care, there have been no comprehensive reports evaluating the effectiveness and clinical application of the dressings to date. The purpose of this study is to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing on caesarean section surgical site and to provide user experience and clinical data for reference by patients and clinical personnel.

Primary Outcome Measures: REEDA scale, The scale includes five factors that indicate abdominal wound healing: redness, edema, ecchymosis, discharge, and approaching wound edges. Each improvement factor is evaluated by giving 0, 1, 2 and 3 points. The sum of the scores obtained as a result of the evaluation of five categories constitutes the REEDA score. The lowest score on the scale is 0, and the highest score is 15. The highest score on the scale indicates severe perineal trauma., Assessing on post-operative day 2, 4 & 11|Percentage of surgical wound infection, The definition of surgical site infection will be according to CDC definitions of nosocomial surgical site infections: a modification of CDC definitions of surgical wound infection., Assessing on post-operative day 2, 4 & 11 if there are any surgical site infection
Secondary Outcome Measures: Percentage of allergic reaction to experimental dressings, The incidence of allergic reaction related to the experimental dressings will be recorded. The final wound check will be performed by the surgeon at 11 days postoperatively., Within 11 days after surgery|Intensity of pain during dressing removal, Pain intensity is assessed by Numerical Rating Scale (NRS). Numerical Rating Scale was a 11-point scale on which 0 represented "no pain" and 10 represented the" worst pain ever"., Assessing on post-operative day 2, 4 & 11|Incidence of adverse events, The incidence of postoperative adverse events related to the experimental dressings will be recorded., Within 11 days after surgery|Number of dressing change, Subjects will take home 2 pieces of experimental dressings and change by themselves. Number of dressing change will be recorded at 11 days postoperatively., Within 11 days after surgery|Satisfaction survey, Subjects' and caregivers' satisfaction survey regarding user experience quantified with the use of a 5-grade scale with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'., Assessing on post-operative day 2, 4 & 11