Jinnah Postgraduate Medical Centre
Karachi, Sindh, 74600, Pakistan
Location contact
Dr Aourangzaib Balouch, mbbs/fcps
PRINCIPAL_INVESTIGATOR
Syeda Raza Syeda Raza, mbbs /fcps
CONTACT
NCT Number: NCT07832162
This randomized controlled trial will compare vacuum-assisted closure (VAC) therapy with conventional wound dressings for the treatment of open contaminated and dirty wounds. The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible patients aged 15 to 60 years with open contaminated or dirty wounds measuring 5-10 cm and classified as American Society of Anesthesiologists (ASA) grade I or II will be randomly allocated to either VAC therapy or conventional dressings. The primary outcome will be mean duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to predefined clinical criteria. The study will compare the duration of wound healing between the two treatment groups.
Trial opening soon.
Get Notified15 year–60 year
All sexes
Interventional
Not applicable
Karachi, Sindh, 74600, Pakistan
Dr Aourangzaib Balouch, mbbs/fcps
PRINCIPAL_INVESTIGATOR
Syeda Raza Syeda Raza, mbbs /fcps
CONTACT
This randomized controlled trial is designed to compare the mean duration of wound healing between vacuum-assisted closure (VAC) therapy and conventional wound dressings in patients with open contaminated or dirty wounds.
The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Patients aged 15-60 years of either sex with open contaminated or dirty wounds measuring 5-10 cm and classified as ASA grade I or II will be considered for inclusion. Written informed consent will be obtained from all participants before enrollment.
A total of 60 participants will be enrolled and randomly allocated in a 1:1 ratio to two parallel treatment groups. Group A will receive VAC therapy, while Group B will receive conventional wound dressings.
All wounds will be thoroughly irrigated with normal saline, and surgical debridement will be performed when clinically indicated. In Group A, the wound will be covered with polyurethane foam, followed by application of an airtight dressing connected to a negative-pressure system. Intermittent negative pressure of 125 mmHg will be applied using cycles of 45 minutes ON and 15 minutes OFF. VAC dressings will be changed every 48-72 hours.
In Group B, saline-soaked conventional dressings will be applied and changed every 24 hours. Participants in both groups will be assessed for wound healing and wound-related complications during the treatment period.
The primary outcome will be mean duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to predefined clinical criteria. Wound surface area may also be assessed as a separate secondary outcome if it is prespecified in the study protocol.
Data will be analyzed using SPSS version 23. Quantitative variables will be assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables will be summarized using mean and standard deviation, while non-normally distributed variables will be summarized using median and interquartile range. Categorical variables will be presented as frequencies and percentages. The duration of wound healing will be compared between groups using an independent-samples t-test or Mann-Whitney U test, as appropriate. A p-value of <0.05 will be considered statistically significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The wound will be covered with polyurethane foam and a multi-hole drain will be placed over it. The dressing will be sealed with an airtight dressing and connected to a negative-pressure system providing intermittent negative pressure of 125 mmHg, with 45 minutes ON and 15 minutes OFF cycles. VAC dressing changes will be performed every 48-72 hours.
Saline-soaked dressing will be placed over the wound and bandage applied, with dressing changes every 24 hours
Time frame: From initiation of treatment until complete wound healing, up to 2 weeks.
Duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to the predefined clinical criteria. The mean duration in days will be compared between the VAC therapy and conventional dressing groups.
Time frame: From initiation of treatment until completion of the 2-week follow-up period.
Frequency of wound infection during the treatment period, based on predefined clinical criteria.
Time frame: During the index hospital admission.
Number of days from hospital admission until discharge.
Time frame: From initiation of treatment until completion of the 2-week follow-up period.
Proportion of participants requiring additional surgical intervention for wound management during the study period.
Contact information is provided by the study sponsor or research team.
Dr Aourangzaib Dr Aourangzaib, MBBS, FCPS
CONTACT
Dr Irfan Dr Irfan, mbbs
CONTACT
Jinnah Postgraduate Medical Centre
Other Gov
Comparison of Mean Duration of Wound Healing Between Vacuum-Assisted Closure (VAC) and Conventional Dressings for the Treatment of Wounds in Patients
Acronym: VAC-WOUND
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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.
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