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Trial no.:
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PACTR202408461234743 |
Date of Approval:
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08/08/2024 |
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Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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| TRIAL DESCRIPTION |
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Public title
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Comparison of negative pressure wound therapy and conventional wound dressing in gapped abdominal wounds among patients admitted at Iringa Regional referral hospital and Dodoma Regional referral hospital. Randomized Control trial (RCT) in resource limited settings. |
| Official scientific title |
Comparison of negative pressure wound therapy (NPWT) and conventional wound DRESSING (CWD) in gapped abdominal wounds among patients admitted at Iringa Regional referral hospital and Dodoma Regional referral hospital. Randomized Control trial (RCT) in resource limited settings |
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Brief summary describing the background
and objectives of the trial
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Wound care is a common medical challenge it requires special attention for its better outcome. In clinical practice many wounds are slow to heal and difficult to manage (Jones et al., 2005). Abdominal wounds are often prone to infection (Heller et al., 2006). Impairment of abdominal wound healing might show up as either spontaneous dehiscence or the requirement for reopening. Surgical site infections, along with other patient-related variables such malnourishment, advanced age, and alcohol misuse, frequently result in impaired abdominal wound healing. (Fagerdahl and Boström, 2012).
Treatment options for abdominal wounds exists that include conventional wound therapy (CWD) and the use of negative pressure wound therapy (NPWT).
Conventional wound therapy is an elementary treatment modality for treatment of wounds, it involves wound daily dressing changes with gauze, lint, plasters, bandages and application of antimicrobial cream protecting the wound from contaminations (Gabriel Akopian n.d.).
Surgical site infection has being the most common (77.5%) reported complication faced with CWD (Mbunda et al. 2012).
Negative pressure wound therapy, also known as vacuum-assisted wound closure, describes wound dressing systems that apply sub atmospheric pressure to the system on a continuous or sporadic basis, creating a positive pressure on the wound's surface. (Mba and Okenwa 2021).
Negative pressure wound therapy has been developed to try to overcome these challenges.
A standard industrial made VAC system consist of portable vacuum machine, suction canister and adhesive dressing packages, Where by the patients need to change three times in a week, this cost around 94.01 US dollars per day (Kim, Gottlieb, and Song 2014).
The appliances are not readily available in most parts of the country including Dodoma and Iringa regional hospitals. Hospitals in the resource limited setting had developed a less expensive, gauze based NPWT (Amouzou et al. 2018)
BROAD OBJECTIVE
To compare effectiveness of improvised negative pressure wound therapy with conventional wound dressing in infected abdominal wounds among admitted patients at IRRH and DRRH.
SPECIFIC OBJECTIVES
1. To assess the outcome of improvised NPWT on infected/gapped abdominal wounds among admitted patients at IRRH and DRRH
2. To determine the outcome of conventional wound dressing on infected/gapped abdominal wounds among admitted patients at IRRH and DRRH
3. To compare clinical outcome of improvised NPWT and CWD on infected/gapped abdominal wounds among patients admitted at IRRH and DRRH
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| Type of trial |
RCT |
| Acronym (If the trial has an acronym then please provide) |
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| Disease(s) or condition(s) being studied |
Skin and Connective Tissue Diseases,Surgery |
| Sub-Disease(s) or condition(s) being studied |
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| Purpose of the trial |
Treatment: Devices |
| Anticipated trial start date |
01/10/2024 |
| Actual trial start date |
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| Anticipated date of last follow up |
30/09/2025 |
| Actual Last follow-up date |
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| Anticipated target sample size (number of participants) |
80 |
| Actual target sample size (number of participants) |
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| Recruitment status |
Not yet recruiting |
| Publication URL |
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