| CTRI Number |
CTRI/2025/02/081073 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [TYPE OF DRESSING MATERIAL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Acticoat and Collagen Dressings for Healing Donor Sites After Skin Grafts: A Study Summary |
|
Scientific Title of Study
|
Outcome Analysis of the application of Acticoat dressing
versus Collagen Dressings in Split-Thickness Skin Graft Donor area
Healing: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijith V |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Burns and plastic surgery
First floor
D block
Raipur
CHHATTISGARH
492099
India |
| Phone |
09400030251 |
| Fax |
|
| Email |
sreevalsam456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jiten Kumar Mishra |
| Designation |
Associate Professor and head |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of burns and plastic surgery
First floor
D block
Raipur
CHHATTISGARH
492099
India |
| Phone |
7008286369 |
| Fax |
|
| Email |
mishra.jitenkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijith V |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Burns and plastic surgery
First floor
D block
Raipur
CHHATTISGARH
492099
India |
| Phone |
09400030251 |
| Fax |
|
| Email |
sreevalsam456@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur, Chhattisgarh, India,492099 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Tatibandh
Raipur
Chhattisgarh
492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ABHIJITH V |
All India Institute of Medical Sciences |
Department of Burns and Plastic surgery
First floor
D block
Raipur
CHHATTISGARH |
09400030251
sreevalsam456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institute Ethics Committee,All India Institute of Medical Sciences, Raipur , Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Application of acticoat dressing versus collagen dressing over skin graft donor site |
Comparing the outcome of skin graft donor site wound healing after application of collagen dressing versus acticoat dressing |
| Intervention |
Application of Acticoat over skin graft donor site |
Acticoat dressing will be applied over the skin graft donor area to look for wound healing and will be changed every 5 days till day 14 |
| Intervention |
Application of collagen dressing over skin graft donor site |
Collagen dressing will be applied once over the skin graft donor area to look for wound healing and will be opened after 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients admitted under Department of Burns and Plastic Surgery AIIMS,Raipur undergoing split thickness skin grafting with a wound size more than 8cm2
2. Age above 18 years and below 60 years
3. Patients giving consent for the study
4. Patients who are willing for post-operative follow-up |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Patient likely to undergo MRI (Magnetic Resonance Imaging) examination during the
initial postoperative period with acticoat dressing insitu
3. Patients with inadequate nutritional status (Haemoglobin less than 9gm/dl, Total
serum protein less than 5.5gm/dl, serum Albumin less than 3.5gm/dl) or other known
illness that can delay wound healing.
4. Patients and/ or relatives not giving informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIME OF WOUND HEALING |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the post-operative pain at the split thickness skin graft donor site after application of acticoat dressing versus collagen dressing during the dressing change
2. To compare the wound infection at split thickness skin graft donor site after acticoat dressing versus collagen dressing
3. To compare the scar outcome at the split thickness skin graft donor site (By Modified Vancouver scar scale)
4. To compare the requirement of analgesic during the first 3 days of post- operative
period
5. To compare the pliability of the scar in both groups using Durometer
6. To compare the need of any secondary surgical procedure for the management of donor site wound |
6 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 18-12-2026 and end date provided 18-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Split thickness skin grafts are now an essential method on the reconstructive ladder and a widely utilized technique for wound reconstruction. Graft donor site wounds create additional challenges due to various morbidities like delayed epithelialization, persistent bleeding, prolonged drainage, pain and scars. Hence care of skin graft donor site is of paramount importance to decrease various morbidities and enhance early wound healing. There is no ideal dressing materials recommended for the care of donor site. Acticoat is a nanocrystalline silver containing dressing material used in the management of various partial and full thickness wounds. Collagen is a biomaterial that encourages wound healing through deposition and organization of freshly formed fibres and granulation tissue in the wound bed thus creating a good environment for wound healing. To our knowledge, there is no literature comparing the outcome of two modalities and hence our study may provide more insight to this aspect. The hypothesis for the study is Application of acticoat dressing over split thickness skin graft donor site provide better wound healing than collagen dressing. |