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An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.
The trial is unblinded randomised trial on surgical wound dressing at 24 versus 48 hours after the emergency caesarean delivery in labour.
The primary outcome is the prevalence of wound complications (hematoma, seroma, infection/ dehiscence) The secondary objectives are the maximum pain after the surgery (in ward) and the timing of the patient's first bath after the surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dressing removal at 24 hours | Active Comparator | The wound dressing will be removed 24 hours after emergency cesarean delivery |
|
| Dressing removal at 48 hours | Placebo Comparator | The wound dressing will be removed 48 hours after emergency cesarean delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cesarean wound dressing removal | Procedure | The cesarean wound dressing is to be removed and the surgical wound exposed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean wound complication | Hematoma, seroma, wound infection, wound dehiscence | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain control | Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain) | 48 hours |
| Self hygiene | Timing of first bath after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zahar A Zakaria, MD | Hospital Kemaman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Kemaman | Kampong Kemaman | Terengganu | 24000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27018465 | Result | Peleg D, Eberstark E, Warsof SL, Cohen N, Ben Shachar I. Early wound dressing removal after scheduled cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):388.e1-5. doi: 10.1016/j.ajog.2016.03.035. Epub 2016 Mar 25. | |
| 32312139 | Result | Kilic GS, Demirdag E, Findik MF, Tapisiz OL, Sak ME, Altinboga O, Sak S, Unlu BS, Evsen MS, Zeybek B, Borahay M, Kuo YF. Impact of timing on wound dressing removal after caesarean delivery: a multicentre, randomised controlled trial. J Obstet Gynaecol. 2021 Apr;41(3):348-352. doi: 10.1080/01443615.2020.1736015. Epub 2020 Apr 21. |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
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| 48 hours |
| 32202035 | Result | Tan PC, Rohani E, Lim M, Win ST, Omar SZ. A randomised trial of caesarean wound coverage: exposed versus dressed. BJOG. 2020 Sep;127(10):1250-1258. doi: 10.1111/1471-0528.16228. Epub 2020 Apr 16. |
| 32266018 | Result | Zhang T, Zhang F, Chen Z, Cheng X. Comparison of early and delayed removal of dressing following primary closure of clean and contaminated surgical wounds: A systematic review and meta-analysis of randomized controlled trials. Exp Ther Med. 2020 May;19(5):3219-3226. doi: 10.3892/etm.2020.8591. Epub 2020 Mar 11. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |