Is absorbable gelatin sponge a better post operative dressing than traditional dressings after surgery on the head?

Efficacy of absorbable gelatin sponge dressing compared to any traditional form of dressing for neurosurgical patients- a randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/05/004643

Enrollment

Registered

2014-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- All patients who undergo emergency cranial neurosurgical procedure and who require a postoperative dressing over the scalp

Interventions

Intervention1: Absorbable gelatin foam dressing: The test intervention is done by placing 2 cm broad absorbable gelatin sponge over the incision site immediately after suturing and then placing gauze

Eligibility

Inclusion criteria

Inclusion criteria: All patients who undergo emergency cranial neurosurgical procedures

Exclusion criteria

Exclusion criteria: 1. Patients who undergo twist drill craniostomy where the incision is very small (less than 1cm) 2. Patient who undergo cranial neurosurgical procedure through a natural orifice where traditional dressing cannot be applied as in the case of transphenoidal surgery.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be assessment of pain at the time of dressing removal by a visual analogue scale when patient is conscious or in case of unconscious patients,by noting wincing or warding off movements or by noting increase in pulse rate.Timepoint: The primary outcome will be assessment of pain at the time of dressing removal which can occur anytime between post operative day one to five. Usually it will be the third post-operative day. (if dressing is soaked it may be removed even at the same post operative day)	—

Measure

Time frame

The primary outcome will be assessment of pain at the time of dressing removal by a visual analogue scale when patient is conscious or in case of unconscious patients,by noting wincing or warding off movements or by noting increase in pulse rate.Timepoint: The primary outcome will be assessment of pain at the time of dressing removal which can occur anytime between post operative day one to five. Usually it will be the third post-operative day. (if dressing is soaked it may be removed even at the same post operative day)

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Secondary

Measure	Time frame
bleeding while removing dressingTimepoint: usually after 24 hours and before 5 days;costsTimepoint: five days;Soakage is assessed by the amount of blood or wetness seen through the dressing.Timepoint: Any point before removal of dressing. (usually within 5 days);Sub-galeal hematoma formationTimepoint: within first five days.;surgical site infectionTimepoint: Till discharge from hospital or 30 days, whichever is earlier;Wound healing: whether there is inflammation or wound gapingTimepoint: Till discharge or thirty days, whichever is earlier	—

Measure

Time frame

bleeding while removing dressingTimepoint: usually after 24 hours and before 5 days;costsTimepoint: five days;Soakage is assessed by the amount of blood or wetness seen through the dressing.Timepoint: Any point before removal of dressing. (usually within 5 days);Sub-galeal hematoma formationTimepoint: within first five days.;surgical site infectionTimepoint: Till discharge from hospital or 30 days, whichever is earlier;Wound healing: whether there is inflammation or wound gapingTimepoint: Till discharge or thirty days, whichever is earlier

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Countries

India

Contacts

Public ContactGopalakrishnan Madhavan Sasidharan

Jawaharlal Institute of Post-graduate Medical Education and Research

gopalakrishnanms@yahoo.com919345141431

Outcome results

None listed

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