To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Surgical Wound; Cesarean Section; Surgical Wound Infection
• Intervention / Treatment: Device: HERADERM Hydrogel Wound Dressing (Sterile)

Detailed Description

In this observational, prospective, single-arm study. We aimed to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing (Sterile) on caesarean section surgical site. Written informed consent are obtained before subjects participate in the study. Eligible subjects will be taken initial wound photos and use experimental dressings for postoperative wound care after closure of caesarean section wound site. To evaluate the clinical applicability of the experimental dressings, wound healing assessments will be conducted by independent study nurse during the postoperative period, hospitalization, and follow-up visits. Information of pain intensity experienced by subjects during dressing removal will be collected. Additionally, satisfaction surveys based on subjects' experiences of wearing and changing the experimental dressings will also be collected during the hospitalization and follow-up visits.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects going to have cesarean section in Taipei Veterans General Hospital.

Description

Inclusion Criteria:

1. Age over 18, scheduling for a transverse incision cesarean section, and using HERADERM Hydrogel Wound Dressing (Sterile) for wound care at the end of the surgery.
2. Gestational age over 37 weeks on the day of the cesarean section.
3. Body mass index (BMI) less than 35 kg/m² on the day of the cesarean section.
4. Subjects must be able to comply with follow-up wound care visits and subsequent monitoring.

Exclusion Criteria:

1. Subjects unwilling to sign the consent form or with poor compliance.
2. Currently suffering from severe immune-related skin diseases, such as severe urticaria, generalized eczema, pemphigus, lupus erythematosus, etc.
3. Using medications that affect wound healing (e.g., glucocorticoids, anticoagulants and immunosuppressive drugs).
4. Subjects were deemed unsuitable for participation by investigator, such as uncontrolled infection and conditions that interfere with wound healing.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Experimental: HERADERM Hydrogel Wound Dressing (Sterile); Eligible subjects will use experimental dressings for postoperative wound care after caesarean section. The subjects received dressing change on the second day after surgery and on the day of discharge. After discharge, subjects will take home 2 pieces of experimental dressings and change by themselves. (Timing to change dressing after discharge: the area of exudate exceeds two-thirds of the dressing area)

Device: HERADERM Hydrogel Wound Dressing (Sterile); HERADERM Hydrogel Wound Dressing (Sterile) is a transparent, composite hydrogel dressing. The outer layer is a waterproof and breathable polyurethane film (PU film), which can prevent external bacterial invasion and reduce the risk of infection. The inner layer is A+ polymer hydrogel, which can keep the wound bed in a moist state and reduce the infiltration problem caused by wound exudate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Chia-Hao Liu, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cesarean section; surgical site infection; wound healing; wound care; HERADERM Hydrogel Wound Dressing (Sterile)
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Surgical Wound; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: 2024-08-023AC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No