A study to compare the wound dressings in post cancer surgery wound

A randomized study to compare the safety and effectiveness of Theruptor NXT Non-Adherent Wound Dressing over Standard of care dressing in Post-operative wound management of Oncological surgeries

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/05/052574

Enrollment

102

Registered

2023-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z480- Encounter for attention to dressings, sutures and drains

Interventions

Intervention1: Theruptor NXT Non adherent wound dressing: Theruptor NXT Non adherent wound dressing is an active advanced wound care product. It consists of a 3-D Knitted Hydrocellular textile substra

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing uncomplicated oncological surgeries in the opinion of the investigator and who needs more then or equal to 5 cm of surgical incision 2.Patients with clean or clean contaminated surgical wound 3.Willing to give written informed consent for the study

Exclusion criteria

Exclusion criteria: 1.Patients with systemic infection and/or local infection at the site of surgery 2.Patients with life expectancy less than 6â??months 3.Patients participating in another clinical trial less than 30 days before participation in this trial 4.Investigatorâ??s discretion

Design outcomes

Primary

Measure	Time frame
To evaluate incidence of surgical site infection using CDC criteria for SSITimepoint: Post surgery day 2 Day of discharge Post surgery day 30	—

Secondary

Measure	Time frame
To assess Cosmetic appearance of the wound using Modified Hollander Wound ScoreTimepoint: Post surgery day 2 Day of discharge Post surgery day 30;To evaluate adverse events among the two groupsTimepoint: Day of surgery Post surgery day 2 Day of discharge Post surgery day 30;To Evaluate ease of application usage removal of the dressing using Product Usage Assessment Scale on a 5 point scale with 5 being excellent and 1 being poorTimepoint: Day of surgery Post surgery day 2;To evaluate subject satisfaction on wound dressing among the two groups Subjects will be asked to rate on comfort of dressing on a 5 point scale with 5 being excellent and 1 being poorTimepoint: Post surgery day 2;To evaluate wound pain using 10-point Visual Analog Scale (VAS) scoreTimepoint: Post surgery day 2 Day of discharge Post surgery day 30	—

Measure

Time frame

To assess Cosmetic appearance of the wound using Modified Hollander Wound ScoreTimepoint: Post surgery day 2 Day of discharge Post surgery day 30;To evaluate adverse events among the two groupsTimepoint: Day of surgery Post surgery day 2 Day of discharge Post surgery day 30;To Evaluate ease of application usage removal of the dressing using Product Usage Assessment Scale on a 5 point scale with 5 being excellent and 1 being poorTimepoint: Day of surgery Post surgery day 2;To evaluate subject satisfaction on wound dressing among the two groups Subjects will be asked to rate on comfort of dressing on a 5 point scale with 5 being excellent and 1 being poorTimepoint: Post surgery day 2;To evaluate wound pain using 10-point Visual Analog Scale (VAS) scoreTimepoint: Post surgery day 2 Day of discharge Post surgery day 30

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Countries

India

Contacts

Public ContactDr Amritha Prabha

Vydehi Institute of Medical Sciences and Research Centre

amrithaprabhag@gmail.com9945333333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026