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

NCT ID: NCT06558240

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2025-01-31

Brief 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.

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.

Conditions

Cesarean Section; Surgical Wound; Surgical Wound Infection; Wounds and Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

HERADERM Hydrogel Wound Dressing (Sterile)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chia-Hao Liu

Visiting Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chia-Hao Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2024-08-023AC

Identifier Type: -

Identifier Source: org_study_id