NCT06558240

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-08-16
• Last updated: 2025-04-11

Locations

1 site across 1 country: Taiwan