Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Intensity of pain during dressing removal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects going to undergo cesarean section
Not provided
Subjects going to have cesarean section in Taipei Veterans General Hospital.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chia-Hao Liu, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D013530 | Surgical Wound Infection |
| D014947 | Wounds and Injuries |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided