Skip to main content
OpenTrials
Completed

NCT Number: NCT06558240

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section Genital Diseases Infections Infertility Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Surgical Wound Infection Urogenital Diseases Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Gestational age over 37 weeks on the day of the cesarean section.
  • Body mass index (BMI) less than 35 kg/m² on the day of the cesarean section.
  • Subjects must be able to comply with follow-up wound care visits and subsequent monitoring.

Exclusion criteria

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

Treatment and study plan

HERADERM Hydrogel Wound Dressing (Sterile)

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.

Primary outcomes

  1. REEDA scale

    Time frame: Assessing on post-operative day 2, 4 & 11

    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.

  2. Percentage of surgical wound infection

    Time frame: Assessing on post-operative day 2, 4 & 11 if there are any surgical site 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.

Secondary outcomes

  1. Percentage of allergic reaction to experimental dressings

    Time frame: Within 11 days after surgery

    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.

  2. Intensity of pain during dressing removal

    Time frame: Assessing on post-operative day 2, 4 & 11

    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".

  3. Incidence of adverse events

    Time frame: Within 11 days after surgery

    The incidence of postoperative adverse events related to the experimental dressings will be recorded.

  4. Number of dressing change

    Time frame: Within 11 days after surgery

    Subjects will take home 2 pieces of experimental dressings and change by themselves. Number of dressing change will be recorded at 11 days postoperatively.

  5. Satisfaction survey

    Time frame: Assessing on post-operative day 2, 4 & 11

    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'.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.