Benifits of Using Diathermy in Skin Incision Clinical Trial
Official title:
Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section
| Verified date | March 2021 |
| Source | National Research Centre, Egypt |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.
| Status | Completed |
| Enrollment | 476 |
| Est. completion date | January 31, 2021 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: - women with a history of only one previous cesarean section - age between 18 and 40 years - gestational age of 38 to 41 weeks - body mass index less than 30. Exclusion Criteria: - any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound. - Women who conducted primary or emergency cesarean deliveries - cardiac patients on pacemakers - patients on anticoagulants - women refusing to participate in the study |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | National Research Centre | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| National Research Centre, Egypt | Kasr El Aini Hospital |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | incision time | We compared incisional time by using a digital clock. The incisional time was established as follows: when skin incision was made, the surgeon called out "start the clock". Once the rectus sheath was visualized, the surgeon calls out "stop the clock". The incision time was the difference between "start" and "stop". | during surgical operation. the difference between starting skin incision till the rectus sheath was visualized | |
| Primary | incision blood loss | This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved. | during surgery | |
| Primary | postoperative pain | We compared those patients clinically for postoperative pain for 24 hours by visual analog scale (VAS) score, a psychometric response scale, and it is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is 11 points numeric scale ranges from "0" representing one pain extreme (e.g., no pain) to "10" representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). This score was recorded for each participant at 2,4,6,8,10,12,24 hours postoperatively. | during the first day after surgery | |
| Secondary | wound healing | healing by primary versus secondary intention | during the first week after surgery | |
| Secondary | wound complications | like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection | during the first week after surgery |